Use of Symbols in Labeling, 38911-38931 [2016-13989]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Rules and Regulations]
[Pages 38911-38931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 660, 801, and 809

[Docket No. FDA-2013-N-0125]
RIN 0910-AG74


Use of Symbols in Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
issuing this final rule revising its medical device and certain 
biological product labeling regulations to explicitly allow for the 
optional inclusion of graphical representations of information, or 
symbols, in labeling (including labels) without adjacent explanatory 
text (referred to in this document as ``stand-alone symbols'') if 
certain requirements are met. The final rule also specifies that the 
use of symbols, accompanied by adjacent explanatory text continues to 
be permitted. FDA is also revising its prescription device labeling 
regulations to allow the use of the symbol statement ``Rx only'' or 
``[rx] only'' in the labeling for prescription devices.

DATES: This rule is effective September 13, 2016.

FOR FURTHER INFORMATION CONTACT: For information concerning the final 
rule as it relates to devices regulated by the Center for Devices and 
Radiological Health (CDRH): Antoinette (Tosia) Hazlett, Center for 
Devices and Radiological Health, Food and Drug Administration, Bldg. 
66, Rm. 5424, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-6119, email: Tosia.Hazlett@fda.hhs.gov.
    For information concerning the final rule as it relates to devices 
regulated by the Center for Biologics Evaluation and Research: Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    The final rule explicitly permits the use of symbols in medical 
device labeling without adjacent explanatory text if certain 
requirements are met. The medical device industry has requested the 
ability to use stand-alone symbols on domestic device labeling, 
consistent with their current use on devices manufactured for European 
and other foreign markets. The final rule seeks to harmonize the U.S. 
device labeling requirements for symbols with international regulatory 
requirements, such as the Medical Device Directive 93/42/EEC of the 
European Union (EU) (the European Medical Device Directive) and global 
adoption of International Electrotechnical Commission (IEC) standard 
IEC 60417 and International Organization for Standardization (ISO) 
standard ISO 7000-DB that govern the use of device symbols in numerous 
foreign markets.

Summary of the Major Provisions of the Regulatory Action in Question

    FDA has generally interpreted existing regulations not to allow the 
use of symbols in medical device labeling, except with adjacent 
English-language explanatory text and/or on in vitro diagnostic (IVD) 
devices intended for professional use. Under the final rule, symbols 
established in a standard developed by a standards development 
organization (SDO) may be used in medical device labeling without 
adjacent explanatory text as long as: (1) The standard is recognized by 
FDA under its authority under section 514(c) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(c)) and the symbol is used 
according to the specifications for use of the symbol set

[[Page 38912]]

forth in FDA's section 514(c) recognition, or alternatively, (2) if the 
symbol is not included in a standard recognized by FDA under section 
514(c) or the symbol is in a standard recognized by FDA but is not used 
according to the specifications for use of the symbol set out in the 
FDA section 514(c) recognition, the device manufacturer otherwise 
determines that the symbol is likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use in 
compliance with section 502(c) of the FD&C Act (21 U.S.C. 352(c)) and 
uses the symbol according to the specifications for use of the symbol 
set forth in the SDO-developed standard. In addition, in either case, 
the symbol must be explained in a paper or electronic symbols glossary 
that is included in the labeling for the medical device. Furthermore, 
the labeling on or within the package containing the device must bear a 
prominent and conspicuous statement identifying the location of the 
symbols glossary that is written in English or, in the case of articles 
distributed solely in Puerto Rico or in a Territory where the 
predominant language is one other than English, the predominant 
language may be used. As with text used in device labeling, the use of 
symbols must also comply with other applicable labeling requirements in 
the FD&C Act, such as section 502(a) and section 502(f), and relevant 
regulations such as 21 CFR part 801. In addition, the final rule allows 
the use of the symbol statement ``Rx only'' or ``[rx] only'' for 
labeling of prescription devices.

Costs and Benefits

    Benefits represent the reduction in costs associated with designing 
and redesigning the labeling for medical devices that are currently 
marketed in the United States and the EU. We estimate these annual cost 
savings to roughly range between $7.9 million and $25.5 million at a 3 
percent discount rate, and $7.7 million to $25 million at a 7 percent 
discount rate. Costs represent the one-time administrative costs to 
redesign labeling to incorporate a new or changed symbol, to the one-
time costs to create a symbols glossary that is included in the 
labeling for the device, and the recurring costs to revise these 
glossaries, as necessary. Annualized over a 20-year period, we estimate 
these costs to range from $1.1 million to $3.2 million. Annualized over 
a 20-year period, we estimate total annualized net to range from $6.8 
million to $22.3 million at a 3 percent discount rate, and from $6.6 
million to $21.7 million at a 7 percent discount rate.
    The use of stand-alone symbols in device labeling is optional under 
the final rule. Those device manufacturers who now use labels without 
symbols, or who use symbols with adjacent explanatory text, may 
continue to do so. Therefore, medical device manufacturers would use 
stand-alone symbols as allowed by the final rule only if they expect a 
positive net benefit (estimated benefits minus estimated costs). Hence, 
the final rule is expected to provide a net benefit to manufacturers 
who opt to use the stand-alone symbols as allowed under this final 
rule.

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                                   Total benefits annualized   Total costs annualized      Total net benefits
 Summary of costs and benefits of      over 20 years (in          over 20 years (in     annualized over 10 years
        the proposed rule                  millions)                  millions)               (in millions)
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    Total........................  $7.7 to $25.5............  $1.1 to $3.2............  $6.6 to $22.3.
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Table of Contents

I. Background
II. Comments on the Proposed Rule and FDA's Responses
    A. Options for Using Stand-Alone Symbols
    B. Matters Relating to the Extent to Which Symbols Can Be Used
    C. Labeling Information Not Required by or Under the Authority 
of the FD&C Act
    D. Validation of Stand-Alone Symbols Contained in Standards Not 
Recognized by FDA or Recognized for Only a Subset of Symbols, 
Devices, or Users
    E. Symbols Glossary Requirement
    F. Implementation of the Final Rule
    G. Symbol Statement ``Rx Only'' or ``[rx] Only''
III. Compliance and Enforcement
IV. Legal Authority for the Final Rule
V. Economic Analysis of Impacts
VI. Paperwork Reduction Act of 1995
VII. Analysis of Environmental Impacts
VIII. Effective Date
IX. Federalism
X. References

I. Background

    FDA published a proposed rule to revise certain medical device and 
biological product labeling regulations by explicitly allowing labeling 
to contain certain stand-alone symbols. The proposed rule would allow 
stand-alone use of symbols in device labeling if the symbol is 
established as part of a standard developed by a nationally or 
internationally recognized standards organization, is part of a 
standard recognized by FDA for use in the labeling for medical devices, 
and is explained in a symbols glossary that contemporaneously 
accompanies the medical device (78 FR 23508, April 19, 2013). The 
preamble to the proposed rule describes the background and the purpose 
of the rule as well as discusses that FDA recognition of the standard 
in which the symbol is contained would be under its authority in 
section 514(c) of the FD&C Act (21 U.S.C. 360d(c)). We refer readers to 
that preamble for information about the development of the proposed 
rule. The Agency requested public comments on the proposed rule, and 
the comment period closed on June 18, 2013.
    As discussed further in section II.A, in this final rule FDA is 
making the following changes to the regulatory text of the final rule 
as compared to the proposed rule: (1) Deleting the term ``standardized 
symbol'' as that term was used in the proposed rule to refer only to 
symbols in FDA recognized standards and the scope of this final rule 
allows other alternatives; (2) providing that, in addition to symbols 
in a standard recognized by FDA under section 514(c) of the FD&C Act, 
the use of certain other SDO-established symbols is allowed; (3) 
clarifying that the symbols glossary must ``be included in the labeling 
for the device,'' in lieu of using the words ``contemporaneously 
accompanies'' the device, providing that such glossary can be in paper 
or electronic form, and that the labeling on or within the package 
containing the device must bear a prominent and conspicuous statement 
identifying the location of the symbols glossary; (4) adding a 
definition of what we mean by the term ``standards development 
organization (SDO)'' for purposes of this final rule; and (5) revising 
the definition of ``symbols glossary'' to mean a compiled listing of: 
(a) Each SDO-established symbol used in the labeling for the device; 
(b) the title and the designation number of SDO-developed standard 
containing the symbol; (c) the title of the symbol and its reference 
number, if any, in the standard; and (d) the meaning or explanatory 
text for the symbol as provided in the FDA recognition, or if FDA has 
not recognized the standard or portion of the standard in which the 
symbol is located or the symbol is not

[[Page 38913]]

used according to the specifications of the FDA section 514(c) 
recognition, the explanatory text as provided in the standard. In 
addition, in this final rule, we renumbered 21 CFR 660.2(c), 660.28, 
660.35, 660.45, and 660.55 to improve the readability of these 
sections. This final rule also contains conforming amendments to 21 CFR 
660.20(a) and 660.50(a) that update references made in these sections 
to certain of the renumbered provisions. As stated previously, in the 
proposed rule, the Agency proposed to limit use of stand-alone symbols 
in device labeling only to those symbols that an SDO established in a 
standard that FDA recognized under its authority in section 514(c) of 
the FD&C Act. The reason for FDA's reliance on its recognition process 
in the proposed rule as a criterion for allowable stand-alone symbols 
was that the process offered FDA the opportunity to determine that the 
symbol was likely to be read and understood by the ordinary user under 
customary conditions of use as required by section 502(c) of the FD&C 
Act. In part, based on comments discussed in this document, which 
raised issues regarding some aspects of the section 514(c) recognition 
process, the Agency further considered the matter and concluded that 
its recognition process under section 514(c) of the FD&C Act is not the 
only way to ensure that the appropriate section 502(c) determination is 
made. FDA determined that, as an alternative to its section 514(c) 
recognition, manufacturers could themselves determine whether an SDO-
established symbol is likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use in compliance 
with section 502(c) of the FD&C Act. This would be consistent with what 
industry currently does when it uses text in labeling. We note, 
however, that FDA has the authority to make the definitive 
determination regarding compliance with the statute and can take 
enforcement action against violations, as warranted.
    As provided in section 514(c)(1)(B) of the FD&C Act, a person can 
use a standard recognized by FDA to meet a statutory requirement and 
submit a declaration of conformity to FDA to certify that the device is 
in conformity with the standard. Section 514(c)(1)(B) of the FD&C Act 
further provides that a person may elect to use data, or information, 
other than data required by a standard recognized by FDA to meet any 
requirement regarding devices under the FD&C Act. Apart from such 
compliance with the requirements of section 502(c) of the FD&C Act by 
conforming to a standard recognized for that purpose under section 
514(c), the manufacturer must determine itself that the labeling also 
meets the other requirements of the FD&C Act, as it is the 
responsibility of all persons labeling devices to assure statutory and 
regulatory compliance. The final rule acknowledges the device 
manufacturer's responsibility to comply with the requirements of 
section 502(c) of the FD&C Act as well, by permitting the use of a 
stand-alone symbol in labeling that the manufacturer has determined 
meets such requirements. Accordingly, this final rule provides that a 
stand-alone symbol is allowed to be used in device labeling if: (1) The 
symbol is established in a standard developed by an SDO; and (2) the 
standard is recognized by FDA under its authority under section 514(c) 
of the FD&C Act and the symbol is used according to the specifications 
for use of the symbol set forth in FDA's section 514(c) recognition, or 
alternatively, if the symbol is not included in a standard recognized 
by FDA under section 514(c) or the symbol is in a standard recognized 
by FDA but is not used according to the specifications for use of the 
symbol set out in the FDA section 514(c) recognition, the device 
manufacturer otherwise determines that the symbol is likely to be read 
and understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the FD&C Act and 
uses the symbol according to the specifications for use of the symbol 
set forth in the SDO-developed standard. In addition, in either case, 
the symbol must be explained in a paper or electronic symbols glossary 
that is included in the labeling for the medical device. Furthermore, 
the labeling on or within the package containing the device must bear a 
prominent and conspicuous statement identifying the location of the 
symbols glossary that is written in English or, in the case of articles 
distributed solely in Puerto Rico or in a Territory where the 
predominant language is one other than English, the predominant 
language may be used. The additional option to use stand-alone symbols 
established in SDO-developed standards that FDA has not recognized, as 
permitted in the final rule, will result in more timely availability of 
stand-alone symbols for use in device labeling, more convenience for 
industry, and conserves limited Agency resources.
    See section III (Compliance and Enforcement) for our discussion to 
help manufacturers determine, if the symbol is not included in a 
standard or part of a standard that FDA has recognized under section 
514(c) of the FD&C Act or if the symbol is used outside the 
specifications of the FDA section 514(c) recognition, whether the 
stand-alone use of the symbol in device labeling is likely to be read 
and understood by the ordinary individual under customary conditions of 
purchase and use in accordance with section 502(c) of the FD&C Act. In 
section III, we also clarify that the other provisions of section 502 
of the FD&C Act also apply to the use of stand-alone symbols, such as 
section 502(a) of the FD&C Act if use of the symbol in its labeling 
causes the labeling to be false or misleading and section 502(f) of the 
FD&C Act if use of the symbol in device labeling results in inadequate 
directions for use of the device. For clarity, in this final rule, we 
have set out the definition of an ``SDO.'' For purposes of this rule, 
we define an SDO as an organization that is nationally or 
internationally recognized and that follows a process for standard 
development that is transparent (i.e., open to public scrutiny), where 
the participation is balanced, where an appeals process is included, 
where the standard is not in conflict with any statute, regulation, or 
policy under which FDA operates, and where the standard is national or 
international in scope (see 76 FR 23508 at 23511). (See also FDA answer 
to Question 18 (What organizations can develop consensus standards for 
FDA recognition?) in the guidance document entitled ``Frequently Asked 
Questions on Recognition of Consensus Standards; Guidance for Industry 
and FDA Staff'' (September 2007), at. p. 7 (Ref. 1 and cited in the 
proposed rule (76 FR at 23508 at 23509)).

II. Comments on the Proposed Rule and FDA's Responses

    We received submissions from 16 commenters, representing a cross-
section of individuals, professional and trade associations, and device 
manufacturers. Almost all comments supported the objectives of the rule 
in whole or in part. The great majority of comments either suggested 
changes to specific elements of the proposed rule or requested 
clarification of matters discussed in the proposed rule.

A. Options for Using Stand-Alone Symbols

    (Comment 1) Two comments raised the challenges and impracticality 
of FDA authorization of symbols via section 514(c) recognition of the 
standard in which the symbol is established. One of these comments 
expressed concern that, under the

[[Page 38914]]

section 514(c) process, FDA recognition of certain symbols for certain 
devices within the standards will present challenges to industry. For 
instance, ``if FDA does not recognize the newest revisions of the 
standards, discrepancies could require going back to define symbols in 
text on labels.'' Another commenter claimed that by limiting the 
recognition of symbols to certain devices, the Agency would be falling 
considerably short of harmonizing with other regulatory bodies, which 
is one major goal of this rulemaking. The comment went on to state that 
the European Medical Device Directive does not limit the use of 
recognized symbols to certain devices, i.e., does not limit which 
symbols can be used nor does it limit the devices for which a symbol 
can be used as long as the symbol is explained elsewhere in the device 
labeling. The comment opined that requiring independent validation by 
FDA of the stand-alone symbols established in standards would be an 
unnecessary use of FDA resources.
    (Response 1) The changes in the final rule discussed previously 
will address many, if not most, of these commenters' concerns. The 
final rule gives the manufacturer the option of using a symbol 
contained in an FDA recognized standard or determining for itself that 
the SDO-established symbol is likely to be read and understood by the 
customary purchasers and users of the device. Under the final rule, if 
an FDA recognized standard is only for a subset of symbols or a subset 
of devices, the manufacturer could submit its declaration of conformity 
with that standard, and to address any symbols, devices, or users not 
included in the FDA recognition, could determine for itself that use of 
those symbols, on those devices, or for those users meets the 
requirements of section 502(c) of the FD&C Act. This would be 
consistent with what industry currently does when it uses text in 
labeling. We note, however, that FDA has the authority to make the 
definitive determination regarding compliance with the statute and can 
take enforcement action against violations, as warranted. Furthermore, 
manufacturers always have the option to request FDA recognition of 
certain standards if the manufacturer does not want to determine for 
itself the section 502(c) compliance of the use of the stand-alone 
symbol in device labeling. See Guidance for Industry and FDA Staff 
entitled ``Frequently Asked Questions on Recognition of Consensus 
Standards'' (Ref. 1). Because manufacturers are not limited to use of 
stand-alone symbols which are part of an FDA-recognized standard, the 
final rule should not present the challenges raised by the commenters.
    When the symbol is not contained in an FDA-recognized standard, 
this final rule requires that all stand-alone symbols used in device 
labeling be established in a standard developed by an SDO, as is the 
case for FDA recognition of standards under section 514(c) of the FD&C 
Act. Our definition of an SDO is intended to include the attributes 
that are required for voluntary consensus standards bodies, whose 
standards Federal Agencies are allowed to use for regulatory activities 
in lieu of a Government-developed standard. These attributes are 
openness, balance of interest, due process, an appeals process, and 
consensus (Refs. 2 and 3).
    The symbols established in standards developed by SDOs, as defined 
in this final rule, will ordinarily have undergone the SDO's written 
procedures for approval or issuance and validation, and the final rule 
does not impose any additional requirements to revalidate that the 
symbol meets the requirements of section 502(c) of the FD&C Act if it 
is established in an FDA-recognized standard or has been appropriately 
validated by the SDO. See section II.D (FDA response to comments 10 and 
11). As explained in the preamble to the proposed rule, FDA considers 
whether symbols have been validated through the standards development 
organization process when determining whether to recognize the symbols 
(see 76 FR 23508 at 23511). We also note that, contrary to the 
commenters' assertion regarding independent FDA validation of stand-
alone symbols in a standard, FDA, as part of its section 514(c) 
recognition process, does not independently validate the symbols. For 
symbols in standards recognized by FDA under its authority in section 
514(c) of the FD&C Act, FDA will have determined that the standard 
containing the symbol was developed by an SDO and that the SDO used its 
validation procedures in establishing the standard.
    Under the final rule, a stand-alone symbol that is allowed to be 
used in device labeling is a symbol that: (1) Is established in a 
standard developed by an SDO; and (2) is contained in a standard that 
FDA recognizes under section 514(c) of the FD&C Act and is used 
according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition, or alternatively, if the symbol is 
not contained in a standard recognized by FDA under section 514(c) of 
the FD&C Act or the symbol is contained in a standard recognized by FDA 
but is not used according to the specifications for use of the symbol 
set out in the FDA section 514(c) recognition, is determined by the 
manufacturer to be likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use in compliance 
with section 502(c) of the FD&C Act and is used according to the 
specifications for use of such symbol as set forth in such standard. In 
addition, in either case, the stand-alone symbol must be explained in a 
paper or electronic symbols glossary that is included in the labeling 
for the device. Furthermore, the labeling on or within the package 
containing the device must bear a prominent and conspicuous statement 
identifying the location of the symbols glossary that is written in 
English or, in the case of articles distributed solely in Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be used. In device labeling, 
symbols that do not satisfy these criteria must be accompanied by 
adjacent explanatory text.
    (Comment 2) Four comments requested that FDA authorize stand-alone 
use of all the symbols contained in ISO 15223-1:2012. One of these 
comments also encouraged the Agency to consider authorizing stand-alone 
use of the symbols in international standards ISO 7000, ISO 7010, and 
IEC 60417; another asked us to clarify that authorized stand-alone use 
will include the symbols in ANSI/AAMI ES60601-1:2005 and supersede IEC 
60601-1. A separate comment recommended authorizing stand-alone use of 
the symbols in ``ISO standard BS EN 980.''
    (Response 2) As explained earlier in the Background section and 
section II.A (FDA response to Comment 1), this final rule provides 
additional flexibility by permitting the stand-alone use, in device 
labeling, of symbols that are part of a standard recognized by FDA 
under section 514(c) of the FD&C Act, as specified in the proposed 
rule, or, alternatively, a manufacturer can use an SDO-established 
symbol not included in a standard recognized by FDA or a symbol in a 
standard recognized by FDA but not used in accordance with the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition, if it otherwise determines that the symbol is likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase and use in compliance with section 502(c) of the 
FD&C Act. Because FDA recognition of the underlying standard is not the 
only option for manufacturers, they are free to choose to select the

[[Page 38915]]

additional option provided by the final rule with regard to using 
symbols established in the standards referenced in the comments. (See 
also section III regarding compliance and enforcement).
    (Comment 3) Three comments stated that stand-alone symbols, once 
recognized through the section 514(c) process, should be allowed for 
all medical devices, rather than limited to use on any subset of 
devices. All three commenters believed that the Agency's actions in 
authorizing stand-alone symbols for IVD devices in the guidance 
document entitled ``Use of Symbols on Labels and in Labeling of In 
Vitro Diagnostic Devices Intended for Professional Use'' (November 
2004) (the ``IVD Symbols Guidance'') at pp. 7-8 (Ref. 4), and in 
proposing for this rule that standardized symbols should be limited to 
a subset of devices, are confusing when limited use of stand-alone 
symbols is authorized based on device category and user groups.
    (Response 3) FDA plans to continue to recognize symbols under its 
authority in section 514(c) of the FD&C Act for subsets of devices and/
or subsets of users, as appropriate. Because the final rule does not 
limit the use of symbols to those in FDA-recognized standards, 
manufacturers have the option to use stand-alone symbols in the 
labeling for any medical device, as long as the symbol is established 
in a standard developed by an SDO and explained in a symbols glossary 
as provided in the standard and the manufacturer determines that the 
stand-alone symbol on its particular device otherwise satisfies section 
502(c) of the FD&C Act. Because the Agency is providing additional 
flexibility with regard to allowable stand-alone symbols, manufacturers 
are not limited as a result of FDA's recognition of a standard for only 
a subset of symbols, devices, or users. We note that use of stand-alone 
symbols beyond the specifications for use set out in FDA's recognition 
of the standard will require manufacturers to establish section 502(c) 
compliance for those symbols, devices, or users not included in FDA's 
recognition. If the manufacturer determines that the stand-alone symbol 
on its particular device otherwise satisfies section 502(c) of the FD&C 
Act, the manufacturer can use the stand-alone symbol in device labeling 
established in the standard only within the specifications for use of 
the symbol set out in the SDO-developed standard. Otherwise, a symbol 
used outside of the specifications for use set forth in the SDO-
developed standard must be accompanied by adjacent explanatory text. 
See Sec.  801.15(c)(1)(i)(C), as revised, in this final rule.
    CDRH encourages stakeholders to recommend appropriate standards for 
FDA recognition under section 514(c) of the FD&C Act by following the 
instructions located at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

B. Matters Relating to the Extent to Which Symbols Can Be Used

1. Proprietary Symbols
    (Comment 4) One of the comments stated that medical device 
manufacturers should be permitted to use proprietary symbols as long as 
the meaning of the proprietary symbol is described in documentation 
supplied with the device. The comment points out that the European 
Medical Device Directive allows the use of a symbol not developed as 
part of a standard as long as the symbol is defined in the labeling for 
the product.
    (Response 4) We believe the commenter is referring to the provision 
in the EU's 1993 Medical Device Directive which states: ``Any symbol or 
identification colours used must conform to the harmonized standards. 
In areas for which no standards exist, the symbols and colours must be 
described in the documentation supplied with the device.'' That is, the 
comment refers to a proprietary symbol that is not contained in a 
standard. Under the proposed rule and this final rule, for the use of a 
stand-alone symbol in device labeling to be allowed, the symbol must be 
established as part of a standard. In the preamble to the proposed 
rule, the Agency stated that it does not intend to recognize 
proprietary symbols (78 FR 23508 at 23511). This referred to 
proprietary symbols contained in a standard.
    The Agency believes that proprietary symbols, whose use is subject 
to the symbol owner's exclusive rights and not freely available to the 
public, should be outside the SDO standards development process called 
for in the proposed rule and finalized in this rule. See the earlier 
discussion of SDO factors found in the National Technology Transfer and 
Advancement Act of 1995 (Ref. 2) and Circular A-119 (Ref. 3) to be 
considered when a Federal Agency uses standards developed outside the 
Government (Section I. (Background)).
    Circular A-119 also provides that the Government use for regulatory 
purposes of a standard developed by non-Government body must include 
provisions requiring that owners of relevant intellectual property have 
agreed to make that intellectual property available on a non-
discriminatory, royalty-free, or reasonable royalty basis to all 
interested parties (63 FR 8553 at 8554). The term ``proprietary 
symbol,'' and the comment, begs the question of whether such symbol 
would be freely available to the public and whether the symbol's owner 
has retained its exclusive rights. Because this final rule is limited 
to symbols established in standards, it does not allow proprietary 
symbols for use as stand-alone symbols. We note, however, that the rule 
allows use of a proprietary symbol accompanied by explanatory text 
adjacent to the symbol.
2. Pictograms
    (Comment 5) Two comments asked us to clarify that product graphics 
or pictograms included in labeling, for example graphics showing the 
steps for using a device, are outside the scope of the proposed rule. 
One of the comments went further to assert that pictograms do not 
require accompanying English text to explain their meaning.
    (Response 5) We agree that product graphics or pictograms included 
in labeling, for example graphics showing the steps for using a device, 
are outside this rulemaking. Symbols are not allowed for stand-alone 
use in this final rule unless they are established in a standard 
developed by an SDO and such graphics normally are not so established. 
Product graphics are typically unique to the individual product. They 
are not broadly applicable or used across a wide range of devices, and 
are unlikely to be established in an SDO-developed standard. Because 
the final rule is limited to symbols established in a standard, such 
product graphics are outside the scope of this final rule.
    The Agency has interpreted its regulations generally to allow 
graphics, pictures, or symbols to meet the labeling requirements of 
this regulation except where it specifies particular labeling language 
(78 FR 23508 at 23509). Having said that, if a stand-alone graphical 
representation communicates required labeling information, such as 
directions for use required by Sec.  801.5, the product graphic alone 
is unlikely to satisfy regulatory requirements, even when used under 
this final rule with accompanying adjacent English text, and further 
labeling may be needed in addition to what this final rule requires to 
explain the meaning of the symbol (see amended Sec. Sec.  660.2(c), 
660.28, 660.35, 660.45, 660.55, 801.15(c)(1) and 809.10.

[[Page 38916]]

3. Symbols Used on Non-Device Medical Products
    (Comment 6) One comment argued that if a symbol is authorized for 
stand-alone use in device labeling, then that symbol should be 
authorized for all medical products, including for drugs or combination 
products. According to the comment, ``a standard FDA recognizes'' means 
a standard adopted ``for all Centers'' and for all FDA-regulated 
products, not just devices. While acknowledging the ``procedural 
issues'' associated with extending the scope of the final rule to non-
device medical products, the commenter recommended flexibility 
``through enforcement discretion'' until the regulations for drugs and 
non-device biological products can be updated to conform to the use of 
stand-alone symbols on medical devices.
    (Response 6) The proposed rule would have authorized the stand-
alone use of symbols explained in a symbols glossary included in the 
device labeling and contained in a standard recognized under section 
514(c) of the FD&C Act, a provision applicable to medical devices only. 
The final rule also provides for the use in device labeling of stand-
alone symbols if they are established in standards developed by an SDO, 
the manufacturer determines that the symbols are likely to be read and 
understood by the ordinary individual under customary conditions of use 
and purchase and the symbols are explained in a paper or electronic 
symbols glossary that is included in the labeling for the device. 
Because this rulemaking revises only the device and certain biological 
product labeling regulations, labeling for other FDA-regulated products 
is outside the scope of this rulemaking. Manufacturers considering the 
use of stand-alone symbols in labeling for other-FDA regulated products 
should contact the appropriate Center for the product regarding the 
permissibility of such use.
4. Combination Products
    (Comment 7) One comment asked us to clarify how the rule applies to 
combination products, i.e., to medical products containing not only a 
device constituent but also a drug or biological product, for example, 
a drug/device combination.
    (Response 7) Stand-alone symbols may be used in accordance with the 
final rule in the labeling applicable to a combination product as a 
whole if the primary mode of action (PMOA) for the product (see 21 CFR 
3.2(k) and (m)) is that of a device. Stand-alone symbols may also be 
used in any separate labeling for the device constituent part of a 
combination product, regardless of the PMOA for the combination product 
(e.g., any separate labeling for the device constituent part of a 
convenience kit or other copackaged combination product, see Sec.  
3.2(e)(2)).
    The appropriate use of stand-alone symbols in any other labeling 
associated with combination products is beyond the scope of this 
rulemaking. Manufacturers considering the use of stand-alone symbols in 
such other labeling for combination products should contact the lead 
Center for the product regarding the permissibility of the proposed 
use.

C. Labeling Information Not Required by or Under the Authority of the 
FD&C Act

    (Comment 8) When adequate directions for use are known to the 
ordinary individual, some devices may be exempt from adequate 
directions for use (Sec.  801.116; see section 502(f)(1) of the FD&C 
Act). Some prescription devices are likewise not required to bear 
adequate directions for use if practitioners licensed by law to use the 
device are commonly aware of the directions, hazards, warnings, and 
other information necessary to use the device safely and for the 
purpose for which it is intended (Sec.  801.109(c)).
    Three comments suggested that manufacturers marketing devices that 
are exempt from adequate directions for use under Sec.  801.116 or 
Sec.  801.109(c) would needlessly be burdened under this final rule to 
create a symbols glossary to explain symbols that they are using 
voluntarily to display information that is not required ``by or under'' 
the FD&C Act.
    (Response 8) The final rule requires a symbols glossary when a 
stand-alone symbol is used to provide labeling information required by 
or under the authority of the FD&C Act. (Sec.  801.15(c)(1)). The 
commenters' understanding of FDA authority ``by or under'' the FD&C Act 
is too narrowly focused on the regulations concerning adequate 
directions for use under section 502(f)(1).
    A device that is exempt from section 502(f)(1) of the FD&C Act 
under Sec.  801.116 or Sec.  801.109(c) may still be required to 
include certain information in its labeling for other purposes in order 
to provide a reasonable assurance of the safety and effectiveness of 
the device. For example, a prescription device that is exempt from 
section 502(f)(1) of the FD&C Act must still include, under Sec.  
801.109(c), indications, effects, routes, methods, and frequency and 
duration of administration, and any relevant hazards, 
contraindications, side effects, and precautions in its labeling.
    Whether or not a medical device is exempt by regulation from 
section 502(f)(1) of the FD&C Act, the device is still subject to the 
other misbranding provisions of section 502. Consequently, we disagree 
that directions-for-use symbols voluntarily used on devices exempt from 
adequate directions for use under Sec.  801.116 or Sec.  801.109(c) 
should be categorically exempt from the symbols glossary requirement 
and the final rule.
    (Comment 9) In discussing the symbols glossary requirement, the 
preamble to the proposed rule stated therefore, any stand-alone symbol 
on the labeling for a device that conveys directions for use would be 
subject to the symbols glossary requirements (78 FR 23508 at 23511). 
One commenter interpreted this statement as limiting the symbols 
glossary requirement to symbols for directions-for-use information 
only. The commenter requested clarification that, under the final rule, 
use of a symbol that does not convey directions for use, such as ``the 
manufacturing site symbol, lot symbol, etc.,'' should therefore not 
trigger the symbols glossary requirement.
    (Response 9) The preamble statement quoted in the comment refers to 
directions-for-use symbols as an example, and not by way of limitation; 
but we agree that clarification is appropriate.
    FDA device labeling regulations specifically require information 
other than just directions for use, including the examples mentioned in 
the comment. For example, under Sec.  801.1(a), the device label must 
identify the name and address of the manufacturer, packer, or 
distributor of the device. If an FDA-allowed stand-alone symbol is 
used, for example, in place of the wording ``manufacturer:'' or 
``manufacturing site:'' followed by a name and address, the final rule 
requires that a symbols glossary must be included in the labeling for 
the device to explain the meaning of the symbol to the device's user. 
There are many FDA regulations that require device labeling 
information; and the final rule, including the symbols glossary 
requirement, applies to any device using a stand-alone symbol to 
provide such information.

D. Validation of Stand-Alone Symbols Contained in Standards Not 
Recognized by FDA or Recognized for Only a Subset of Symbols, Devices, 
or Users

    (Comment 10) One comment asked the Agency to ensure that each 
stand-alone symbol authorized under this rule

[[Page 38917]]

can be relied upon and be used by device manufacturers, without 
separate validation by the manufacturer for its use on a specific 
device. Another comment asked us to clarify that FDA would not 
unnecessarily use its resources to revalidate symbols established in an 
SDO-developed standard.
    (Response 10) The symbols established in standards developed by 
SDOs will ordinarily have undergone the SDO's written procedures for 
approval or issuance and validation (78 FR 23508 at 23511). In the 
validation process, studies can demonstrate end-user comprehension of 
the stand-alone symbol in the device labeling context; and validation 
data specifically applicable to medical devices may be submitted to the 
SDO for its review (78 FR 23508 at 23510, see for example AAMI/ANSI/ISO 
15223-2:2010 (Part 2), Symbol Development, Selection and Validation).
    The final rule does not impose any additional requirements on 
device manufacturers to revalidate that such symbols meet the 
requirements of section 502(c) of the FD&C Act if the symbol is 
established in an FDA-recognized standard or has been appropriately 
validated by the SDO. FDA does not intend to invite requests for it to 
validate or to revalidate a symbol allowed under the rule, i.e., a 
stand-alone symbol established in an SDO-developed standard and 
explained in the device labeling. However, we will consider information 
as appropriate, including post-market surveillance data indicating that 
a symbol used on a particular device is not understood by device users 
(section 502(c) of the FD&C Act), or that it causes the labeling to be 
false or misleading (section 502(a)), results in inadequate directions 
for use of the device (section 502(f)), or otherwise causes the device 
labeling to violate the misbranding provisions of section 502.
    (Comment 11) One comment questioned why, if the validation process 
includes consumer testing, there was no analysis of this cost burden.
    (Response 11) The final rule does not impose any new requirements 
for public participation in the standards development processes of SDOs 
or for the establishment of symbols in SDO-developed standards. The 
final rule does not affect the paperwork burden or cost associated with 
the standards-development process establishing a symbol allowed by the 
final rule, and therefore, no cost estimate or economic analysis of the 
process is required.
    The final rule establishes certain procedures and conditions for 
device manufacturers to use a symbol as a stand-alone symbol on medical 
device labeling, including specifically, that the symbol must be 
explained in a symbols glossary that is included in the labeling for 
the device. The proposed and final rules do analyze the paperwork 
burden and economic cost of these procedures and conditions, including 
the required symbols glossary.
    The burden on persons seeking SDO development of standards 
establishing symbols, including the validation of those symbols in the 
standard, is a matter already considered under existing standards-
development norms and is otherwise in the control of the relevant SDO. 
The final rule does not require the interested party to revalidate that 
the stand-alone symbol meets the requirements of section 502(c) of the 
FD&C Act if the symbol is established in an FDA-recognized standard or 
has been appropriately validated by the SDO. Any validation needed in 
order to comply with the requirements of section 502(c) of the FD&C Act 
is under the requirements of that statute, and is not being imposed by 
this final rule. Accordingly, there is no validation process required 
by the final rule, and no cost estimate or economic analysis is called 
for in the rule.

E. Symbols Glossary Requirement

    (Comment 12) Four comments state that, in the case of stand-alone 
symbols established in an SDO-developed standard, a symbols glossary 
``contemporaneously accompanying'' the device is unnecessary. Three of 
these comments specifically refer to the symbols contained in ISO 
15223-1 and contend that the symbols glossary requirement does not 
harmonize with the European Medical Device Directive or with ISO 15233 
because neither one requires an accompanying symbols glossary. 
Alternatively, one comment suggested that the final rule should 
establish a sunset limitation for the symbols glossary requirement, so 
that, for example, the glossary rule would expire 2 years after the 
publication of the final rule.
    (Response 12) FDA disagrees with the comments that its symbols 
glossary requirement is not necessary and does not harmonize with the 
European Medical Directive or with ISO 15233. The European Medical 
Device Directive states that ``[i]n areas for which no standards exist, 
the symbols and colours must be described in the documentation supplied 
with the device.'' The Directive does not otherwise preclude requiring 
documentation with such symbols. Many of the symbols contained in ISO 
15223-1 explicitly restrict their use as follows: ``In Europe, this 
symbol shall be explained in the information supplied by the 
manufacturer.'' FDA is aware of many device manuals containing a 
symbols glossary that would comply with this final rule, and has in the 
past considered this a good practice. Furthermore, the IVD Symbols 
Guidance (Ref. 4) recommends that a glossary of terms accompany each 
IVD to define all the symbols used on that device's label and/or 
labeling (at pp. 7-8). Following the effective date of this final rule, 
FDA intends to withdraw the IVD Symbols Guidance.
    Concerning the comment recommending a sunset limitation on the 
symbols glossary requirement, the Agency disagrees. The symbols 
glossary is intended to allow users to become familiar with the meaning 
of the symbols and also acts as a reference for users to look up any 
definitions they may not recall. In these respects, the symbols 
glossary helps to satisfy, although it does not satisfy on its own, the 
requirements of section 502(c) of the FD&C Act by making it more likely 
that users under customary conditions of purchase and use have access 
to necessary reference materials to help them understand the symbols. 
Accordingly, we do not believe that a sunset limitation on the symbols 
glossary requirement is appropriate.
    (Comment 13) Four comments requested FDA to clarify the meaning of 
the term ``contemporaneously accompanies the device'' in the symbols 
glossary requirement of the rule, in particular whether the term 
includes ``all varieties of written or electronic materials that are 
connected to a manufacturer's marketing and sale of a product, even 
when the materials are not physically with the medical device.'' Two of 
these commenters believe that, in the case of prescription devices, the 
rule should permit electronic display of the symbols glossary under 
section 502(f) of the FD&C Act and that such electronic labeling should 
be treated as accompanying the device for purposes of the rule. One 
comment urged that a reference in the medical device labeling to an 
online FDA glossary should satisfy the glossary requirement. Another 
stated that electronic labeling is an accepted practice for IVDs in the 
EU.
    (Response 13) In the proposed rule, one of the requirements for use 
of stand-alone symbols was that such symbols be explained in a symbols 
glossary that contemporaneously accompanies the device. FDA understands 
that the term ``contemporaneously accompanies'' in the proposed rule 
may have prompted

[[Page 38918]]

confusion, and we are revising the codified language of the final rule 
to clarify that a stand-alone symbol must be explained in a paper or 
electronic symbols glossary that is ``included in the labeling for the 
device.'' We agree that flexibility is possible and appropriate to 
satisfy the symbols glossary requirement. The new wording permits 
flexibility in the form of the symbols glossary, as long as the 
glossary is included in the labeling for the device.
    Furthermore, this final rule allows device manufacturers to provide 
the symbols glossary by electronic means. We have changed the codified 
to read ``the symbol . . . is explained in a paper or electronic 
symbols glossary that is included in the labeling for the device.'' 
(See amended Sec. Sec.  660.2(c), 660.28, 660.35, 660.45, 660.55, and 
801.15(c)(1), and new Sec.  809.10(g).) That is, the symbols glossary 
can be provided by electronic means so long as the glossary is included 
in the labeling for the device. This change also takes into account the 
provisions of section 502(f) of the FD&C Act which provides that 
required labeling for certain prescription devices and certain IVD 
devices may be made available solely by electronic means. (See section 
502(f) (``by electronic means'')).
    In the proposed rule, we inadvertently did not specify that the 
labeling of the device must direct the purchaser and user as to the 
location of the symbols glossary in the labeling for the device. 
Without directions as to the location of the symbols glossary in the 
labeling, the purpose of the symbols glossary would not be served. 
Therefore, this final rule provides that the symbol is explained in a 
paper or electronic symbols glossary that is included in the labeling 
for the device and the labeling on or within the package containing the 
device bears a prominent and conspicuous statement identifying the 
location of the symbols glossary. For example, the statement could read 
``The symbols glossary is provided [specify, e.g., in Section X of the 
package insert, as a separate insert within the package, on the side 
panel of the package, electronically at (insert URL address to symbols 
glossary on manufacturer's Web site)].'' The statement must be in 
English or, in the case of articles distributed solely in Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be used.
    In the proposed rule, the term ``symbols glossary'' was defined in 
the codified as ``a compiled listing of each symbol used in the 
labeling of the device and of the meaning of or explanatory text for 
the symbol.'' We are revising the codified language in the final rule 
to define ``symbols glossary'' as ``compiled listing of: (1) Each SDO-
established symbol used in the labeling for the medical device; (2) the 
title and designation number of the SDO-developed standard containing 
the symbol; (3) the title of the symbol and its reference number, if 
any, in the standard; and (4) the meaning or explanatory text for the 
symbol as provided in the FDA recognition, or if FDA has not recognized 
the standard or portion of the standard in which the symbol is located 
or the symbol is not used according to the specifications for use of 
the symbol set forth in FDA's section 514(c) recognition, the 
explanatory text as provided in the standard (see amended Sec. Sec.  
660.2(c), 660.28, 660.35, 660.45, 660.55, and 801.15(c) and new Sec.  
809.10(g)). In finalizing the rule, we revised the ``symbols glossary'' 
definition to help accurately identify the SDO-developed standard 
containing the symbol and the symbol in the standard.
    (Comment 14) One comment argued that a single copy of the glossary 
should satisfy the rule when the same devices are shipped together in a 
multipack. Another comment argued that replacement parts or disposable 
components servicing the device with stand-alone symbols in their 
labeling should be exempt from the glossary rule because the customer 
would already have received the glossary information with the original 
purchase of the device.
    (Response 14) In both of these situations, the premise is that 
there is a stand-alone symbol that appears in the labeling for the 
individual device unit or the replacing component.
    Typically, a replacement part for a medical device or disposable 
component is used later in time than the replaced component. The 
glossary delivered to the user with the original equipment might no 
longer be available to explain the meaning of the stand-alone symbol on 
the labeling for a replacement part. ``Any component, part, or 
accessory'' of a device, if its intended use is to service the device, 
is itself a device (section 201(h) of the FD&C Act (21 U.S.C. 321(h))). 
Under the final rule, the symbols glossary requirement therefore 
applies separately to replacement or disposable components when the 
labeling for the replacing component bears a stand-alone symbol because 
the symbols glossary must be included in the labeling for the device.
    Additionally, the individual units of a multipack shipment, like 
replacement components, are likely to be used later such that the 
glossary delivered to the user of a multipack shipment might no longer 
be retained and available to explain the meaning of the stand-alone 
symbol on the labeling for the remaining individual units after the 
multipack is broken and the first unit or units are used. Under the 
final rule, the symbols glossary requirement therefore applies to the 
individual devices of a multipack shipment when the labeling for the 
individual units bears a stand-alone symbol because the symbols 
glossary must be included in the labeling for the device.
    To reduce the burden of the glossary requirement for individual 
devices of a multipack shipment, manufacturers should consider the 
final rule's provision for use of an electronic symbols glossary. Such 
electronic glossary, however, must be included in the labeling for the 
device. In such situations, FDA requires that the labeling for the 
device must prominently and conspicuously include the URL address for a 
Web site that displays the symbols glossary on the manufacturer's Web 
site explaining the meaning of the stand-alone symbols used on that 
device's labeling.

F. Implementation of the Final Rule

    (Comment 15) One comment asked FDA to clarify how much time 
manufacturers will have to convert existing symbols in labeling to 
stand-alone symbols.
    (Response 15) In the final rule, there is no required conversion to 
stand-alone symbols. The final rule does not mandate the use of stand-
alone symbols. The use of stand-alone symbols is an alternative to 
labeling without symbols and to the currently-allowed use of symbols 
with adjacent explanatory text. Effective beginning on September 13, 
2016 (see section VIII), the final rule expressly provides for the use 
of symbols accompanied by adjacent explanatory text in the device 
labeling (amended Sec. Sec.  660.2(c), 660.28, 660.35, 660.45, 660.55, 
and 801.15(c)(1) and new Sec.  809.10(g)) and the use of stand-alone 
symbols that meet the requirements of the rule.
    (Comment 16) One comment asked FDA to clarify whether manufacturers 
need to file a new 510(k) notification under 21 CFR part 807, subpart E 
or a Premarket Approval (PMA) supplement under 21 CFR part 814 when 
they replace symbols currently used with adjacent English text with 
stand-alone symbols and a symbols glossary in the device labeling.
    (Response 16) In most cases, manufacturers who wish to update their 
device or product labeling only by

[[Page 38919]]

substituting text with one or more stand-alone symbols allowed under 
the rule, or to remove explanatory text adjacent to such symbols 
(without making any changes to the meaning of the labeling), do not 
need to submit a new premarket submission prior to making that change. 
In some cases FDA may require, through regulation or order, through a 
special controls guideline, or on a case-by-case basis in reviewing 
premarket submissions, specific language in device labeling, or may 
require or prohibit use of symbols in a specific labeling context. For 
example, devices subject to a boxed-warning labeling requirement must 
strictly adhere to the exact language of the applicable regulation, and 
any use of symbols in the warning should be reviewed and specifically 
allowed by FDA in advance of such use.
    For medical devices with an approved PMA, manufacturers may 
generally replace required information in existing labeling with 
equivalent stand-alone symbols that are allowed under the rule without 
the need to submit a PMA supplement. PMA holders that implement this 
type of change should notify the Agency of the change in the next 
annual report to the PMA, in accordance with Sec.  814.84. As with 
510(k)-cleared devices, however, in some cases FDA may require, through 
regulation or order, or on a case-by-case basis during premarket 
review, specific language in device labeling, or may require or 
prohibit use of symbols in a specific labeling context.
    Similarly, applicable biologics license holders that replace 
required information with stand-alone symbols that are allowed under 
the rule on the labeling for licensed products also regulated as 
devices should notify the Agency of the change in the next annual 
report to the manufacturer's Biologics License Application (BLA), in 
accordance with 21 CFR 601.12(f)(3)(i)(A); and the Agency will consider 
the change to be an editorial or similar minor change.
    Manufacturers may substitute stand-alone symbols that are allowed 
under the rule for equivalent text on existing labels and labeling for 
medical devices that received premarket notification (510(k)) clearance 
without submitting a new 510(k) notification. For information on other 
labeling changes that might require submission of a new 510(k) 
notification, please see Sec.  807.81(a)(3).
    (Comment 17) Three comments urged FDA to maintain close cooperation 
and communication with industry in order to implement timely updates of 
the list of symbols permitted for stand-alone use through its 
standards-recognition process and to keep up with the revision of 
current international standards.
    (Response 17) Under this final rule, any stand-alone symbol 
established in an SDO-developed standard and used in accordance with 
the specifications of the standard is allowed, regardless of whether or 
not FDA recognizes the standard or the part of the standard containing 
the symbol, under section 514(c) of the FD&C Act. Under the final rule, 
symbols established in a standard developed by an SDO may be used in 
medical device labeling without adjacent explanatory text as long as: 
(1) The standard is recognized by FDA under its authority under section 
514(c) of the FD&C Act and the symbol is used according to the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition, or alternatively, (2) if the symbol is not included in a 
standard recognized by FDA under section 514(c) of the FD&C Act or the 
symbol is in a standard recognized by FDA but is not used according to 
the specifications for use of the symbol set out in the FDA section 
514(c) recognition, the device manufacturer otherwise determines that 
the symbol is likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use in compliance 
with section 502(c) of the FD&C Act and uses the symbol according to 
the specifications for use of the symbol set forth in the SDO-developed 
standard. In addition, in either case, the symbol must be explained in 
a paper or electronic symbols glossary that is included in the labeling 
for the device. Furthermore, the labeling on or within the package 
containing the device must bear a prominent and conspicuous statement 
identifying the location of the symbols glossary that is written in 
English or, in the case of articles distributed solely in Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be used. Although FDA will 
continue to participate with SDOs in the standards development process 
and some of those standards may involve symbols in device labeling, the 
final rule will not require the close industry coordination and 
communication with FDA in order for firms to comply with the rule 
because of its additional flexibility.
    (Comment 18) One comment recommended that when the Agency does not 
recognize all the symbols established in a standard for stand-alone 
use, it should clearly state why any rejected symbol is not included in 
order for interested parties to get ``insights needed to validate the 
symbols.''
    (Response 18) Under the final rule, the fact that FDA does not 
recognize all the symbols established in a standard does not preclude a 
manufacturer from determining that the stand-alone use of the symbol is 
likely to be read and understood by the ordinary individual under 
customary conditions of use and purchase. Therefore, the Agency will 
not provide explanations of why it does not include certain symbols in 
a standard in its recognition under section 514(c) of the FD&C Act as 
requested by the commenter.

G. Symbol Statement ``Rx Only'' or ``[rx] Only''

    (Comment 19) Two comments related to the provision of the rule 
authorizing use of the symbol statement ``Rx Only.'' One comment asked 
whether validation will be required in order to use ``Rx Only'' on a 
prescription device. The second comment asked whether FDA will be 
issuing guidance to support use of the symbol statement ``Rx Only.''
    (Response 19) This final rule does not require validation by the 
device manufacturer in order for it to use the symbol statement ``Rx 
Only'' on its prescription device. The symbol statement ``Rx Only'' has 
a separate statutory and regulatory history unrelated to the use of 
standards as allowed in this final rule.
    As explained in the preamble to the proposed rule, section 126(a) 
of the FDA Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), 
amending section 503(b)(4) of the FD&C Act (21 U.S.C. 353(b)(4)), 
allows use of this symbol statement on the labels of drug products in 
place of a full prescription use statement that indicates that the drug 
must be dispensed with a clinician's prescription. FDAMA did not 
explicitly make the permitted use of ``Rx Only'' applicable to medical 
devices; however, the Agency published the guidance document entitled 
``Alternative to Certain Prescription Device Labeling Requirements,'' 
January 2000 (the Rx Only Statement Guidance) (Ref. 5) stating that FDA 
would exercise enforcement discretion for the use of ``Rx Only'' on 
prescription device labels. FDA's reason for issuing that guidance 
document was a desire to minimize the burden of creating device labels 
and to make it flexible consistent with the statutorily permitted use 
of the ``Rx Only'' symbol statement for prescription drug products. In 
this rule, FDA is expressly allowing for use of ``Rx Only'' for the 
labels of prescription devices to give device manufacturers the option 
to use ``Rx Only'' in lieu of the longer statement currently in the 
regulations. FDA has included this change in this rulemaking given the 
changes involving symbols that the final

[[Page 38920]]

rule is making to other sections of FDA's labeling regulations.
    Because the statutory authority for using the symbol statement ``Rx 
Only'' for drug products, and our purpose and intent in this final rule 
extending it to prescription devices, are clear and satisfy the 
misbranding requirements of section 502 of the FD&C Act pertaining to 
the symbol statement ``Rx Only,'' the Agency does not intend to issue a 
new guidance document regarding the use of ``Rx Only.'' We only restate 
in this document what we said in the preamble to the proposed rule 
about using the symbol statement ``Rx Only.'' It is important to note 
that the word ``only'' must immediately follow the symbol ``Rx.'' 
However, the symbol statement ``Rx only'' does not necessarily need to 
be bracketed in quotation marks, and the word ``only'' may appear in 
upper or lower case letters, for example, Rx only, Rx Only, or Rx ONLY. 
As in the case of labels for prescription drugs, the new label 
statement for prescription medical devices may be printed as either 
``Rx only'' or ``[rx] only.'' (See 67 FR 4904, February 1, 2002.) The 
symbol statement ``Rx only'' in its entirety, or the [rx] symbol in the 
symbol statement ``Rx only,'' may be printed in bold or in regular 
type.

III. Compliance and Enforcement

    Under the final rule, manufacturers may use symbols in labeling in 
the following scenarios. First, manufacturers may continue to use 
symbols with adjacent explanatory text. See, e.g., Sec.  
801.15(c)(1)(i)(C) in this final rule.
    Second, manufacturers may use a stand-alone symbol if the symbol is 
contained in a standard that FDA recognizes under its authority in 
section 514(c) of the FD&C Act for use on the labeling for medical 
devices (or on a subset of medical devices), is used according to the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition, and is explained in a paper or electronic symbols glossary 
that is included in the labeling for the device and the labeling on or 
within the package containing the device bears a prominent and 
conspicuous statement identifying the location of the symbols glossary. 
See, e.g., Sec.  801.15(c)(1)(i)(D) in this final rule. In this second 
scenario, FDA has, through the section 514(c) recognition process, made 
a determination that the symbol, is likely to be read and understood by 
the ordinary individual under customary conditions of purchase and use 
in compliance with section 502(c) of the FD&C Act. In this second 
scenario where a manufacturer wishes to use a stand-alone symbol that 
is in an SDO standard that has been recognized by FDA under section 
514(c) to meet a requirement under the FD&C Act, such manufacturer 
would submit a declaration of conformity to FDA that certifies that the 
device is in conformity with the standard.
    In a third scenario, the stand-alone symbol is not included in a 
standard that is recognized under FDA's section 514(c) authority or is 
in a standard that is recognized under FDA's section 514(c) authority 
but is not used according to the specifications for use of the symbol 
set forth in FDA's 514(c) recognition, manufacturers may use such 
symbol as a stand-alone symbol if the symbol has been established in a 
standard developed by an SDO, the manufacturer has made a determination 
that the symbol in the labeling for a particular device is likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase and use in compliance with section 502(c) of the 
FD&C Act, and such symbol is explained in a paper or electronic symbols 
glossary that is included in the labeling for the medical device, and 
the labeling on or within the package containing the device bears a 
prominent and conspicuous statement identifying the location of the 
symbols glossary. See, e.g., Sec.  801.15(c)(1)(i)(E) in this final 
rule. In this third scenario where a manufacturer uses a symbol that 
has not been recognized by FDA under section 514(c) of the FD&C Act or 
uses a symbol from an FDA recognized standard but not in accordance 
with the specifications for use of the symbol set forth in FDA's 
section 514(c) recognition, the burden is on the manufacturer to 
determine that the symbol is likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use such 
that the use of the symbol in labeling is in compliance with section 
502(c) of the FD&C Act. See, e.g., Sec.  801.15(c)(1)(i)(E)(3).
    To clarify the requirements of the final rule, we include the 
following example:
    Standard Z is a standard developed by an SDO. The scope of Standard 
Z is cardiac devices according to the specifications for use of the 
standard set forth by the SDO. FDA recognizes the standard for use of 
symbols in labeling for cardiac stents under its section 514(c) 
authority. As such, FDA's recognition is for a subset of the devices 
covered by Standard Z. Manufacturer A wishes to use stand-alone symbols 
(symbols without adjacent explanatory text) from Standard Z on cardiac 
stents. Manufacturer B wishes to use stand-alone symbols from Standard 
Z on cardiac pacemakers. Manufacturer C wishes to use stand-alone 
symbols from Standard Z on biliary stents, which are not cardiac 
devices.
    Under the example, all the manufacturers could legally use the 
symbols from Standard Z with adjacent explanatory text. See, e.g., 
Sec.  801.15(c)(1)(i)(C). Manufacturer A can legally use stand-alone 
symbols from Standard Z in the labeling for cardiac stents, consistent 
with FDA's recognition of Standard Z for cardiac stents. See, e.g., 
Sec.  801.15(c)(1)(i)(D). Manufacturer A must explain the stand-alone 
symbols in a paper or electronic symbols glossary that is included in 
the labeling for the device and the labeling on or within the package 
containing Manufacturer A's device must bear a prominent and 
conspicuous statement identifying the location of the symbols glossary. 
See, e.g., Sec.  801.15(c)(1)(i)(D)(3). The symbol must be used 
according to the specifications of FDA's section 514(c) recognition, 
including the same meaning or explanatory text for the symbol in the 
symbols glossary as provided in FDA's recognition of Standard Z. See, 
e.g., Sec.  801.15(c)(1)(i)(D)(2). As discussed again later, if FDA 
subsequently withdraws recognition of Standard Z because the stand-
alone symbol is not likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use, Manufacturer 
A must stop using the stand-alone symbol. If FDA withdraws its 
recognition of Standard Z for other reasons, the Manufacturer A may 
continue to use the stand-alone symbols from Standard Z, that FDA no 
longer recognizes, for cardiac stents (see, e.g., Sec.  
801.15(c)(1)(i)(E)(2)); but the use must be consistent with the 
specifications of Standard Z, including use of the explanatory text as 
provided in Standard Z (see, e.g., Sec.  801.15(c)(1)(i)(E)(4)), and 
the burden is on Manufacturer A to determine that the symbol's use is 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use (see, e.g., Sec.  
801.15(c)(1)(i)(E)(3)).
    With regard to Manufacturer B, this manufacturer wishes to use a 
stand-alone symbol from Standard Z that would not be in accordance with 
the specifications for use of the symbol set forth in FDA's section 
514(c) recognition. When FDA recognized Standard Z, the scope of which 
is cardiac devices, it limited the specifications for use of the 
symbols to cardiac stents. Manufacturer B wishes to use the stand-alone 
symbol from Standard Z on cardiac pacemakers.

[[Page 38921]]

Under the final rule, Manufacturer B may use stand-alone symbols 
outside the scope of FDA recognition (see, e.g., Sec.  
801.15(c)(1)(i)(E)(2)), but within the specifications for use of 
Standard Z (see, e.g., Sec.  801.15(c)(1)(i)(E)(4)). In this scenario 
where Manufacturer B uses a symbol from Standard Z that has not been 
recognized under section 514(c) of the FD&C Act, the burden is on 
Manufacturer B to determine that the symbol's use on cardiac 
pacemakers, outside the scope of the FDA recognition, is likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase and use. See, e.g., Sec.  801.15(c)(1)(i)(E)(3). 
The same is true and same provisions apply if Manufacturer A uses a 
stand-alone symbol on cardiac stents that is not in accordance with the 
specifications for use of FDA's section 514(c) recognition. In these 
cases, Manufacturer B (and Manufacturer A, if its use of the stand-
alone symbol is not in accordance with the specifications for use set 
forth in FDA's section 514(c) recognition) must use the stand-alone 
symbols of Standard Z consistent with the specifications for use of the 
symbol set forth in Standard Z, including use of the explanatory text 
as provided in Standard Z. See, e.g., Sec.  801.15(c)(1)(i)(E)(4).
    Finally, Manufacturer C wishes to use stand-alone symbols in 
Standard Z for biliary stents. Under this final rule, this stand-alone 
use is not allowed. As provided in this final rule, the use of stand-
alone symbols must be in accordance with the specifications for use of 
the symbol set forth in the SDO-developed standard. Standard Z, as 
developed by the SDO, specifies that it applies to cardiac devices. As 
such, the use of stand-alone symbols from Standard Z in biliary stents 
would not be in accordance with the specifications for use of the 
symbols set forth in Standard Z. See, e.g., Sec.  801.15(c)(1)(i)(E)(4) 
in this final rule that requires that a stand-alone symbol be used 
according to the specifications for use of the symbol set forth in the 
SDO-developed standard that FDA does not recognize. Accordingly, 
Manufacturer C's use of the symbols from Standard Z on biliary stents 
would require adjacent explanatory text. See, e.g., Sec.  
801.15(c)(1)(i)(C) in this final rule.
    The final rule does not require the manufacturer to validate for a 
particular device, the stand-alone use of a symbol established in an 
SDO-developed standard, or part of a standard, that FDA has recognized 
under section 514(c) of the FD&C Act. In addition, the final rule does 
not require manufacturers to validate any stand-alone symbol. At the 
same time, this final rule does not preclude device manufacturers from 
undertaking any validation studies needed to assure that the use of the 
stand-alone symbol is likely to be read and understood by customary 
purchasers and users (section 502(c)) and complies with the other 
misbranding requirements of section 502 of the FD&C Act.
    Manufacturers and importers should monitor complaints and adverse 
events that might be related to inadequate understanding of labeling, 
including misunderstanding about the meaning of stand-alone symbols 
used in the device labeling. Manufacturers must report adverse events 
as required by 21 CFR part 803. Reporting forms and instructions are 
available at https://www.fda.gov/medwatch/safety.htm. If, for example, 
postmarket surveillance data such as medical device reporting (MDR) 
suggests that the users of the device do not understand the meaning of 
a particular stand-alone symbol, and that such misunderstanding could 
lead to a safety issue, the Agency may take enforcement action against 
the device and device manufacturer.
    If FDA withdraws recognition of a standard (e.g., Standard Z in the 
example) because the stand-alone symbol is not likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use, in that case, all manufacturers (both Manufacturers A 
and B) must stop using the stand-alone symbol upon withdrawal of 
recognition of the standard. FDA notes that it does not intend to take 
enforcement action under section 502(c) of the FD&C Act on the basis 
that the symbol is not likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use that 
otherwise meets the requirements of this rule unless and until FDA 
issues either a notice of SDO-standard withdrawal applicable to the use 
or a symbol-specific Federal Register notice announcing FDA's 
determination that the symbol is not likely to be read and understood 
by the ordinary individual under customary conditions of purchase and 
use as required by section 502(c), and, as such, the future date on 
which FDA intends to take enforcement action against stand-alone use of 
such symbol.
    In situations where FDA withdraws recognition of a standard, or 
portion thereof, for reasons other than that the stand-alone symbol is 
not likely to be read and understood as required by section 502(c) of 
the FD&C Act, manufacturers may continue to use symbols within that 
standard without adjacent text if the manufacturer determines that the 
symbol is likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use in compliance with 
section 502(c). Therefore, in the example, if FDA withdraws its 
recognition of Standard Z for use of symbols in labeling for cardiac 
stents for a reason other than that the ordinary individual is not 
likely to read and understand the symbols under customary conditions of 
purchase and use in compliance with section 502(c) of the FD&C Act, 
Manufacturer A and Manufacturer B may continue to use their stand-alone 
symbols under Sec.  801.15(c)(1)(i)(E) in this final rule. If FDA 
provided a meaning or explanatory text in its recognition of Standard 
Z, after the withdrawal Manufacturer A must use the symbols from 
Standard Z according to the specifications of Standard Z, including the 
same meaning or explanation in its symbols glossary as provided in 
Standard Z for any remaining permitted use under the FDA withdrawal 
notice. See, e.g., Sec.  801.15(c)(1)(i)(E)(4) and (iii)(B) in this 
final rule.
    With regard to Manufacturer C, if it uses stand-alone symbols that 
are outside the scope of the SDO-developed standard, FDA intends to 
enforce compliance after the effective date of this final rule. See, 
e.g., Sec.  801.15(c)(1)(ii) in this final rule.

IV. Legal Authority for the Final Rule

    A device is misbranded under section 502(c) of the FD&C Act if any 
word, statement, or other information required by or under authority of 
this act to appear on the label or labeling is not in such terms as to 
render it likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use. Additionally, a device 
is misbranded under section 502(a) of the FD&C Act if its labeling is 
false or misleading in any particular. A device is also misbranded 
under section 502(f) of the FD&C Act unless its labeling bears adequate 
directions for use.
    Under section 201(m) of the FD&C Act, the term ``labeling'' means 
all labels and other written, printed, or graphic matter: (1) Upon any 
article or any of its containers or wrappers or (2) accompanying such 
article. Under section 201(k) of the FD&C Act, the term ``label'' means 
a display of written, printed, or graphic matter upon the immediate 
container of any article; and a requirement made by or under authority 
of the FD&C Act that any word, statement, or other information appear 
on the label shall not be considered to be complied with unless

[[Page 38922]]

such word, statement, or other information also appears on the outside 
container or wrapper, if any there be, of the retail package of such 
article, or is easily legible through the outside container or wrapper.
    Section 514(c)(1)(A) of the FD&C Act authorizes FDA to recognize, 
by publication in the Federal Register, all or part of an appropriate 
standard established by a nationally or internationally recognized 
standard development organization for which a person may submit a 
declaration of conformity in order to meet a premarket submission 
requirement or other requirement under the FD&C Act to which such 
standard is applicable. Section 514(c)(1)(B) of the FD&C Act further 
provides that a person may elect to use data, or information, other 
than data required by a standard recognized by FDA to meet any 
requirement regarding devices under the FD&C Act. Section 514(c)(2) of 
the FD&C Act allows FDA to withdraw recognition of a standard through 
publication of a notice in the Federal Register if FDA determines that 
the standard is no longer appropriate for meeting a device requirement 
under the FD&C Act.
    Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA the 
authority to issue regulations for the efficient enforcement of the 
FD&C Act.

V. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. We believe that the final rule 
is not a significant regulatory action as defined by Executive Order 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule imposes no new burdens, we certify that the 
final rule would not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

Summary

    The final rule would provide medical device manufacturers with the 
option to use symbols established in SDO-developed standards for stand-
alone use in labeling to communicate information to end users. Under 
the final rule, manufacturers would be allowed to substitute labels 
containing only written statements (text-only labels) or symbols with 
adjacent explanatory text with a label containing stand-alone symbols, 
provided that such symbols are established in a standard developed by a 
SDO as long as: (1) The standard is recognized by FDA under its 
authority under section 514(c) of the FD&C Act and the symbol is used 
according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition, or alternatively, (2) if the symbol 
is not included in a standard recognized by FDA under section 514(c) of 
the FD&C Act or the symbol is in a standard recognized by FDA but is 
not used according to the specifications for use of the symbol set out 
in the FDA section 514(c) recognition, the device manufacturer 
otherwise determines that the symbol is likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use and uses the symbol according to the specifications 
for use of the symbol set forth in the SDO-developed standard. In 
addition, in either case, the symbol must be explained in a written or 
electronic symbols glossary that is included in the labeling for the 
medical device. Furthermore, the labeling on or within the package 
containing the device must bear a prominent and conspicuous statement 
identifying the location of the glossary that is written in English or, 
in the case of articles distributed solely in Puerto Rico or in a 
Territory where the predominant language is one other than English, the 
predominant language may be used. The use of such symbols must also 
comply with other applicable labeling requirements of the FD&C Act, 
such as section 502(a) and section 502(f). In addition, the final rule 
allows the use of the symbol statement ``Rx Only'' or ``[rx] only'' for 
labeling of prescription devices.
    Medical device manufacturers would only choose to use stand-alone 
symbols, as allowed by the final rule, if they expect a positive net 
benefit (estimated benefits minus estimated costs). Hence, the final 
rule is expected to provide a non-negative net benefit to each 
manufacturer that opts to use stand-alone symbols. Choosing to use 
stand-alone symbols under the final rule would potentially reduce the 
costs associated with designing and redesigning the labels on medical 
devices that are currently marketed in the United States and the EU. 
The estimated annual benefits range from $7.9 million to $25.5 million 
at a 3 percent discount rate, and $7.7 million to $25.0 million at a 7 
percent discount rate. Those that opt to use stand-alone symbols under 
the rule would incur one-time administrative costs to redesign their 
labeling and create a symbols glossary that is included in the labeling 
for the device, and recurring costs to revise their glossaries, as 
necessary. Annualized over 20 years, we estimate total costs to range 
between $1.1 million to $3.2 million at a 3 percent discount rate, and 
from $1.1 million to $3.3 million at a 7 percent discount rate. 
Annualized over 20 years, net benefits range from $6.8 million to $22.3 
million at a 3 percent discount rate, and from $6.6 million to $21.7 
million at a 7 percent discount rate. The costs and benefits accrue to 
the same entities, however, so any firm making the change to stand-
alone symbols would, on net, reduce costs.
    FDA also examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act. If a rule will have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act requires Agencies to analyze regulatory 
options that would lessen the economic effect of the rule on small 
entities. We estimated the final rule's approximate impact on small 
entities using the percent costs per device distinguishable by 
Universal Product Code (UPC): The ratio between unit labeling costs and 
revenues among small entities. Our estimates indicate that the average 
percent costs per UPC ranges from 0.01 to 0.46 percent. Because 
companies can choose whether or not to use stand-alone symbols under 
the final rule, the Agency concludes that this final rule would not 
have a significant adverse impact on any small entities. Furthermore, 
our analysis suggests that

[[Page 38923]]

companies could reap moderate cost-savings by using stand-alone symbols 
in device labeling. On average, companies that use stand-alone symbols 
under this final rule could expect to receive an average annual cost 
savings ranging from $1,500 to $4,500 per UPC. Because using stand-
alone symbols is expected to lower the marginal cost of producing 
exports, medical device manufacturers, including small entities, may be 
able to increase their production either by starting to export products 
or by exporting more products.
    The full analysis of economic impacts is available in the docket 
for this final rule (FDA-2013-N-0125) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 
6).

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
provisions are provided in the following paragraphs with an estimate of 
the annual reporting and third-party disclosure burdens. Included in 
the estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    Title: Medical Devices: Use of Symbols in Labeling--Glossary to 
Support the Use of Symbols in Labeling.
    Description: FDA is issuing a final rule revising medical device 
and certain biological product labeling regulations by explicitly 
allowing for the optional use in medical device labeling of stand-alone 
symbols established in an SDO-developed standard.
    In particular, FDA will allow the use of stand-alone graphical 
representations of information, or symbols in the labeling for the 
medical devices, if the symbols are established in a standard developed 
by an SDO as long as: (1) The standard is recognized by FDA under its 
authority under section 514(c) of the FD&C Act and the symbol is used 
according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition, or alternatively, (2) if the symbol 
is not included in a standard recognized by FDA under section 514(c) of 
the FD&C Act or the symbol is in a standard recognized by FDA but is 
not used according to the specifications for use of the symbol set out 
in the FDA section 514(c) recognition, the device manufacturer 
otherwise determines that the symbol is likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use and uses the symbol according to the specifications 
for use of the symbol set forth in the SDO-developed standard. In 
addition, in either case, the symbol must be explained in a written or 
electronic symbols glossary that is included in the labeling for the 
medical device. Furthermore, the labeling on or within the package 
containing the device must bear a prominent and conspicuous statement 
identifying the location of the glossary that is written in English or, 
in the case of articles distributed solely in Puerto Rico or in a 
Territory where the predominant language is one other than English, the 
predominant language may be used. The use of such symbols must also 
comply with other applicable labeling requirements of the FD&C Act, 
such as section 502(a) and section 502(f). The final rule also allows 
the use of the symbol statement ``Rx Only'' or ``[rx] only.''
    Description of Respondents: The likely respondents for this 
collection of information are domestic and foreign device manufacturers 
who plan to use stand-alone symbols on the labels and/or labeling for 
their devices marketed in the United States.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses  per   Total  annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary...........................................................           3,000                1            3,000                1            3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of       disclosures     Total  annual   Average  burden    Total hours
                                                                       respondents    per  respondent    disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary...........................................................           3,000                1            3,000                4           12,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden is based on the data in a similar collection 
for recommended glossary and educational outreach approved under OMB 
control number 0910-0553 (Use of Symbols on Labels and in Labeling of 
In Vitro Diagnostic Devices Intended for Professional Use). As such, 
the PRA also covers the requirements of this final rule to submit the 
symbols glossary to FDA in otherwise required submissions during the 
premarket review process and to disclose it to third parties in 
otherwise required device labeling, which means adding to such 
submission or labeling a compiled listing of each SDO-established 
symbol used in the labeling for the device; the title and designation 
number of the SDO-developed standard containing the symbol; and the 
title of the symbol and its reference number, if any, in the standard; 
and the meaning or explanatory text for the symbol as provided in the 
FDA recognition or, if FDA has not recognized the standard or portion 
of the standard in which the symbol is located or the symbol is used 
not in accordance with the specifications for use of the symbol set out 
in the FDA section 514(c) recognition, the explanatory text as provided 
in the standard. We assume that the additional requirement of 
identifying in the symbols glossary the SDO-developed standard 
establishing the symbol and its reference number if any, not included 
in proposed rule,

[[Page 38924]]

results in no significant additional cost burden.
    The information collection provisions in this final rule have been 
submitted to OMB (control number 0910-0740) for review as required by 
section 3507(d) of the Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.
    This final rule refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, subparts A through E have been approved 
under OMB control number 0910-0231; the collections of information in 
21 CFR part 801 and Sec.  809.10 have been approved under OMB control 
number 0910-0485; and the collections of information in Sec. Sec.  
660.2, 660.28, 660.35, 660.45, and 660.55 have been approved under OMB 
control number 0910-0338.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Effective Date

    This rule is effective on September 13, 2016.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

X. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Frequently Asked Questions on Recognition of Consensus Standards; 
Guidance for Industry and FDA Staff, September 2007, available at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm074973.htm.
2. The National Technology Transfer and Advancement Act of 1995 
(Pub. L. 104-113), section 12(d), 110 Stat. 783.
3. Office of Management and Budget, OMB Circular A-119 (63 FR 8546, 
February 19, 1998) (Final Revision).
4. Use of Symbols on Labels and in Labeling of In Vitro Diagnostic 
Devices Intended for Professional Use; Guidance for Industry and FDA 
Staff, FDA, November 2004, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm.
5. Alternative to Certain Prescription Device Labeling Requirements; 
Guidance for Industry, FDA, January 2000, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072747.htm.
6. Use of Symbols in Medical Device Labeling: Final Regulatory 
Impact Analysis; Final Regulatory Flexibility Analysis; Unfunded 
Mandates Reform Act Analysis; available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm.

List of Subjects

21 CFR Part 660

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 809

    Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended), the Public Health Service Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
parts 660, 801, and 809 are amended as follows:

PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR 
LABORATORY TESTS

0
1. The authority citation for part 660 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 
360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.


0
2. Amend Sec.  660.2 by revising paragraph (c) to read as follows:


Sec.  660.2  General requirements.

* * * * *
    (c) Labeling. (1) In addition to the items required by other 
applicable labeling provisions of this subchapter, the following shall 
also be included:
    (i) Indication of the source of the product immediately following 
the proper name on both the final container and package label, e.g., 
human, guinea pig.
    (ii) Name of the test method(s) recommended for the product on the 
package label and on the final container label when capable of bearing 
a full label (see Sec.  610.60(a) of this chapter).
    (iii) A warning on the package label and on the final container 
label if capable of bearing a full label (see Sec.  610.60(a) of this 
chapter) indicating that the product and antigen if supplied, shall be 
handled as if capable of transmitting hepatitis.
    (iv) If the product is dried, the final container label shall 
indicate ``Reconstitution date: ___'' and a statement indicating the 
period within which the product may be used after reconstitution.
    (v) The package shall include a package enclosure providing:
    (A) Adequate instructions for use;
    (B) A description of all recommended test methods; and
    (C) Warnings as to possible hazards, including hepatitis, in 
handling the product and any ancillary reagents and materials 
accompanying the product.
    (2) The applicant may provide the labeling information referenced 
in paragraph (c)(1) of this section in the form of:
    (i) A symbol accompanied by explanatory text adjacent to the 
symbol;
    (ii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act;
    (B) Is used according to the specifications for use of the symbol 
set

[[Page 38925]]

forth in FDA's section 514(c) recognition; and
    (C) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used; or
    (iii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is established in a standard developed by a standards 
development organization (SDO);
    (B) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act or is contained in a standard that is recognized by FDA but is not 
used according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition;
    (C) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the Federal Food, 
Drug, and Cosmetic Act;
    (D) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (E) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used.
    (3) The use of symbols to provide the labeling information 
referenced in paragraph (c)(1) of this section which do not meet the 
requirements of paragraph (c)(2) of this section renders a device 
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic 
Act.
    (4) For purposes of paragraph (c)(2) of this section:
    (i) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (ii) The term ``symbols glossary'' means a compiled listing of:
    (A) Each SDO-established symbol used in the labeling for the 
device;
    (B) The title and designation number of the SDO-developed standard 
containing the symbol;
    (C) The title of the symbol and its reference number, if any, in 
the standard; and
    (D) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.
* * * * *

0
3. Amend Sec.  660.20 by revising paragraph (a) to read as follows:


Sec.  660.20  Blood Grouping Reagent.

    (a) Proper name and definition. The proper name of this product 
shall be Blood Grouping Reagent and it shall consist of an antibody-
containing fluid containing one or more of the blood grouping 
antibodies listed in Sec.  660.28(a)(4).
* * * * *

0
4. Revise Sec.  660.28 to read as follows:


Sec.  660.28  Labeling.

    (a) In addition to the applicable labeling requirements of 
Sec. Sec.  610.62 through 610.65 and Sec.  809.10 of this chapter, and 
in lieu of the requirements in Sec. Sec.  610.60 and 610.61 of this 
chapter, the following requirements shall be met:
    (1) Final container label--(i) Color coding. The final container 
label of all Blood Grouping Reagents shall be completely white, except 
that all or a portion of the final container label of the following 
Blood Grouping Reagents may be color coded with the specified color 
which shall be a visual match to a specific color sample designated by 
the Director, Center for Biologics Evaluation and Research. Printing on 
all final container labels shall be in solid black. A logo or company 
name may be placed on the final container label; however, the logo or 
company name shall be located along the bottom or end of the label, 
outside the main panel.

------------------------------------------------------------------------
           Blood grouping reagent                Color of label paper
------------------------------------------------------------------------
Anti-A.....................................  Blue.
Anti-B.....................................  Yellow.
Slide and rapid tube test blood grouping
 reagents only:
    Anti-C.................................  Pink.
    Anti-D.................................  Gray.
    Anti-E.................................  Brown.
    Anti-CDE...............................  Orange.
    Anti-c.....................  Lavender.
    Anti-e.................................  Green.
------------------------------------------------------------------------

    (ii) Required information. The proper name ``Blood Grouping 
Reagent'' need not appear on the final container label provided the 
final container is distributed in a package and the package label bears 
the proper name. The final container label shall bear the following 
information:
    (A) Name of the antibody or antibodies present as set forth in 
paragraph (a)(4) of this section.
    (B) Name, address (including ZIP code), and license number of the 
manufacturer.
    (C) Lot number, including sublot designations.
    (D) Expiration date.
    (E) Source of product if other than human plasma or serum.
    (F) Test method(s) recommended.
    (G) Recommended storage temperature in degrees Celsius.
    (H) Volume of product if a liquid, or equivalent volume for a dried 
product if it is to be reconstituted.
    (I) If a dried product, to remind users to record the 
reconstitution date on the label, the statement ``RECONSTITUTION DATE 
___. EXPIRES 1 YEAR AFTER RECONSTITUTION DATE.''
    (iii) Lettering size. The type size for the specificity of the 
antibody designation on the labels of a final container with a capacity 
of less than 5 milliliters shall be not less than 12 point. The type 
size for the specificity of the antibody designations on the label of a 
container with a capacity of 5 milliliters or more shall be not less 
than 18 point.
    (iv) Visual inspection. When the label has been affixed to the 
final container, a sufficient area of the container shall remain 
uncovered for its full length or no less than 5 millimeters of the 
lower circumference to permit inspection of the contents. The label on 
a final product container for antibodies Anti-c, Anti-k, or Anti-s 
shall display a bar immediately over the specificity letter used in the 
name, i.e., Anti-c, Anti-k, or Anti-s.
    (2) Package label. The following information shall appear either on 
the package label or on the final container label if it is visible 
within the package.

[[Page 38926]]

    (i) Proper name of the product.
    (ii) Name of the antibody or antibodies present as set forth in 
paragraph (a)(4) of this section.
    (iii) Name, address (including ZIP Code), and license number of the 
manufacturer.
    (iv) Lot number, including sublot designations.
    (v) Expiration date.
    (vi) Preservative used and its concentration.
    (vii) Number of containers, if more than one.
    (viii) Volume or equivalent volume for dried products when 
reconstituted, and precautions for adequate mixing when reconstituting.
    (ix) Recommended storage temperature in degrees Celsius.
    (x) Source of the product if other than human serum or plasma.
    (xi) Reference to enclosed package insert.
    (xii) If a dried product, a statement indicating the period within 
which the product may be used after reconstitution.
    (xiii) The statement: ``FOR IN VITRO DIAGNOSTIC USE.''
    (xiv) The statement: ``MEETS FDA POTENCY REQUIREMENTS.''
    (xv) If human blood was used in manufacturing the product, the 
statement: ``CAUTION: ALL BLOOD PRODUCTS SHOULD BE TREATED AS 
POTENTIALLY INFECTIOUS. SOURCE MATERIAL FROM WHICH THIS PRODUCT WAS 
DERIVED WAS FOUND NEGATIVE WHEN TESTED IN ACCORDANCE WITH CURRENT FDA 
REQUIRED TESTS. NO KNOWN TEST METHODS CAN OFFER ASSURANCE THAT PRODUCTS 
DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS.''
    (xvi) A statement of an observable indication of an alteration of 
the product, e.g., turbidity, color change, precipitate, that may 
indicate possible deterioration of the product.
    (3) Package insert. Each final container of Blood Grouping Reagent 
shall be accompanied by a package insert meeting the requirements of 
Sec.  809.10. If two or more final containers requiring identical 
package inserts are placed in a single package, only one package insert 
per package is required.
    (4) Names of antibodies.

               Blood Group Designation for Container Label
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Anti-A                               Anti-Jk\b\
Anti-A1                              Anti-Js\a\
Anti-A, B                            Anti-Js\b\
Anti-A and B                         Anti-K
Anti-B                               Anti-k
Anti-C                               Anti-Kp\a\
Anti-C\w\                            Anti-Kp\b\
Anti- c                  Anti-Le\a\
Anti-CD                              Anti-Le\b\
Anti-CDE                             Anti-Lu\a\
Anti-Co\b\                           Anti-Lu\b\
Anti-D                               Anti-M
Anti-DE                              Anti-M\g\
Anti-Di\a\                           Anti-N
Anti-E                               Anti-P1
Anti-e                               Anti-S
Anti-Fy\a\                           Anti-s
Anti-Fy\b\                           Anti-U
Anti-I                               Anti-Wr\a\
Anti-Jk\a\                           Anti-Xg\a\
------------------------------------------------------------------------

    (b) The applicant may provide the labeling information referenced 
in paragraph (a) of this section in the form of:
    (1) A symbol accompanied by explanatory text adjacent to the 
symbol;
    (2) A symbol not accompanied by adjacent explanatory text that:
    (i) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act;
    (ii) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (iii) Is explained in a paper or electronic symbols glossary that 
is included in the labeling for the device and the labeling on or 
within the package containing the device bears a prominent and 
conspicuous statement identifying the location of the symbols glossary 
that is written in English or, in the case of articles distributed 
solely in Puerto Rico or in a Territory where the predominant language 
is one other than English, the predominant language may be used; or
    (3) A symbol not accompanied by adjacent explanatory text that:
    (i) Is established in a standard developed by a standards 
development organization (SDO);
    (ii) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act or is contained in a standard that is recognized by FDA but is not 
used according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition;
    (iii) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the Federal Food, 
Drug, and Cosmetic Act;
    (iv) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (v) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used.
    (c) The use of symbols in device labeling to provide the labeling 
information referenced in paragraph (a) of this section which do not 
meet the requirements in paragraph (b) of this section renders a device 
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic 
Act.
    (d) For purposes of paragraph (b) of this section:
    (1) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (2) The term ``symbols glossary'' means a compiled listing of:
    (i) Each SDO-established symbol used in the labeling for the 
device;
    (ii) The title and designation number of the SDO-developed standard 
containing the symbol;
    (iii) The title of the symbol and its reference number, if any, in 
the standard; and
    (iv) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.

0
5. Revise Sec.  660.35 to read as follows:


Sec.  660.35  Labeling.

    (a) In addition to the items required by Sec.  809.10 of this 
chapter and other applicable labeling provisions of this chapter, the 
following information shall be included in the labeling:
    (1)(i) A logo or company name may be placed on the final container 
label, however, the logo or company name

[[Page 38927]]

shall be located along the bottom or end of the label, outside of the 
main panel.
    (ii) If washing the cells is required by the manufacturer, the 
container label shall include appropriate instructions; if the cells 
should not be washed before use, e.g., if washing will adversely affect 
the product, the package insert shall explain.
    (2) The container label of Group O cells shall state:
    ``FOR USE IN DETECTION OF UNEXPECTED ANTIBODIES'' or ``FOR USE IN 
IDENTIFICATION OF UNEXPECTED ANTIBODIES'' or ``NOT FOR USE IN DETECTION 
OR IDENTIFICATION OF UNEXPECTED ANTIBODIES''.
    (3) Except as provided in this section, the container and package 
labels shall state the percentage of red blood cells in the suspension 
either as a discrete figure with a variance of more than [+/-] 1 
percentage unit or as a range the extremes of which differ by no more 
than 2 percentage units. If the stated red blood cell concentration is 
less than 2 percent, the variance shall be no more than [+/-] 0.5 
percentage unit.
    (4) The words ``pooled cells'' shall appear on the container and 
package labels of products prepared from pooled cells. The package 
label or package insert shall state that pooled cells are not 
recommended for pre-transfusion tests, done in lieu of a major 
crossmatch, to detect unexpected antibodies in patients' samples.
    (5) The package insert of a pooled product intended for detection 
of unexpected antibodies shall identify the number of donors 
contributing to the pool. Products designed exclusively for ABO Serum 
Grouping and umbilical cord cells need not identify the number of 
donors in the pool.
    (6) When the product is a multicontainer product, e.g., a cell 
panel, the container label and package label shall be assigned the same 
identifying lot number, and shall also bear a number or symbol to 
distinguish one container from another. Such number or symbol shall 
also appear on the antigenic constitution matrix.
    (7) The package label or package insert shall state the blood group 
antigens that have been tested for and found present or absent on the 
cells of each donor, or refer to such information in an accompanying 
antigenic constitution matrix. Cells for ABO Serum Grouping are exempt 
from this requirement. The package insert or antigen constitution 
matrix shall list each of the antigens tested with only one source of 
antibody.
    (8) The package label or package insert shall bear the cautionary 
statement: ``The reactivity of the product may decrease during the 
dating period.''
    (9) The package insert of a product intended for the detection or 
identification of unexpected antibodies shall note that the rate at 
which antigen reactivity (e.g., agglutinability) is lost is partially 
dependent upon individual donor characteristics that are neither 
controlled nor predicted by the manufacturer.
    (10) The package insert shall provide adequate directions for use.
    (11) The package insert shall bear the statement:
    ``CAUTION: ALL BLOOD PRODUCTS SHOULD BE TREATED AS POTENTIALLY 
INFECTIOUS. SOURCE MATERIAL FROM WHICH THIS PRODUCT WAS DERIVED WAS 
FOUND NEGATIVE WHEN TESTED IN ACCORDANCE WITH CURRENT FDA REQUIRED 
TESTS. NO KNOWN TEST METHODS CAN OFFER ASSURANCE THAT PRODUCTS DERIVED 
FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS.''
    (12) The package insert or the antigenic constitution matrix for 
each lot of product shall specify the date of manufacture or the length 
of the dating period.
    (13) Manufacturers shall identify with a permanent donor code in 
the product labeling each donor of peripheral blood used for detection 
or identification of unexpected antibodies.
    (b) The applicant may provide the labeling information referenced 
in paragraph (a) of this section in the form of:
    (1) A symbol accompanied by explanatory text adjacent to the 
symbol;
    (2) A symbol not accompanied by adjacent explanatory text that:
    (i) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act;
    (ii) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (iii) Is explained in a paper or electronic symbols glossary that 
is included in the labeling for the device and the labeling on or 
within the package containing the device bears a prominent and 
conspicuous statement identifying the location of the symbols glossary 
that is written in English or, in the case of articles distributed 
solely in Puerto Rico or in a Territory where the predominant language 
is one other than English, the predominant language may be used; or
    (3) A symbol not accompanied by adjacent explanatory text that:
    (i) Is established in a standard developed by a standards 
development organization (SDO);
    (ii) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act or is contained in a standard that is recognized by FDA but is not 
used according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition;
    (iii) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the Federal Food, 
Drug, and Cosmetic Act;
    (iv) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (v) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used.
    (c) The use of symbols in device labeling to provide the labeling 
information referenced in paragraph (a) of this section which do not 
meet the requirements of paragraph (b) of this section renders a device 
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic 
Act.
    (d) For purposes of paragraph (b) of this section:
    (1) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (2) The term ``symbols glossary'' means a compiled listing of:
    (i) Each SDO-established symbol used in the labeling for the 
device;
    (ii) The title and designation number of the SDO-developed standard 
containing the symbol;
    (iii) The title of the symbol and its reference number, if any, in 
the standard; and

[[Page 38928]]

    (iv) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.

0
6. Revise Sec.  660.45 to read as follows:


Sec.  660.45  Labeling.

    (a) In addition to the requirements of Sec. Sec.  610.60, 610.61, 
and 809.10 of this chapter, the labeling shall bear the following:
    (1) The ``d and y'' antigen subtype and the source of the product 
to follow immediately the proper name on both the final container label 
and the package label. If the product is intended to identify 
antibodies to the ``r and w'' antigen subtype, the antigen subtype 
designation shall include the ``r and w'' antigen subtype.
    (2) The name of the test method(s) recommended for use of the 
product on the package label and on the final container label, when 
capable of bearing a full label (see Sec.  610.60(a) of this chapter).
    (3) A warning on the package label and on the final container label 
stating that the product is capable of transmitting hepatitis and 
should be handled accordingly.
    (4) The package shall include a package insert providing:
    (i) Detailed instructions for use,
    (ii) An adequate description of all recommended test methods, and
    (iii) Warnings as to possible hazards, including hepatitis 
transmitted in handling the product and any ancillary reagents and 
materials accompanying the product.
    (b) The applicant may provide the labeling information referenced 
in paragraph (a) of this section in the form of:
    (1) A symbol accompanied by explanatory text adjacent to the 
symbol;
    (2) A symbol not accompanied by adjacent explanatory text that:
    (i) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act;
    (ii) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (iii) Is explained in a paper or electronic symbols glossary that 
is included in the labeling for the device and the labeling on or 
within the package containing the device bears a prominent and 
conspicuous statement identifying the location of the symbols glossary 
that is written in English or, in the case of articles distributed 
solely in Puerto Rico or in a Territory where the predominant language 
is one other than English, the predominant language may be used; or
    (3) A symbol not accompanied by adjacent explanatory text that:
    (i) Is established in a standard developed by a standards 
development organization (SDO);
    (ii) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act or is contained in a standard that is recognized by FDA but is not 
used according to the specifications for use of the symbol set forth in 
FDA's section 514(c) recognition;
    (iii) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the Federal Food, 
Drug, and Cosmetic Act;
    (iv) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (v) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used.
    (c) The use of symbols in device labeling to provide the labeling 
information referenced in paragraph (a) of this section which do not 
meet the requirements of paragraph (b) of this section renders a device 
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic 
Act.
    (d) For purposes of paragraph (b) of this section:
    (1) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (2) The term ``symbols glossary'' means a compiled listing of:
    (i) Each SDO-established symbol used in the labeling for the 
device;
    (ii) The title and designation number of the SDO-developed standard 
containing the symbol;
    (iii) The title of the symbol and its reference number, if any, in 
the standard; and
    (iv) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.

0
7. Amend Sec.  660.50 by revising paragraph (a) to read as follows:


Sec.  660.50  Anti-Human Globulin.

    (a) Proper name and definition. The proper name of this product 
shall be Anti-Human Globulin which shall consist of one or more 
antiglobulin antibodies identified in Sec.  660.55(a)(4).
* * * * *

0
8. Revise Sec.  660.55 to read as follows:


Sec.  660.55  Labeling.

    (a) In addition to the applicable labeling requirements of 
Sec. Sec.  610.62 through 610.65 and Sec.  809.10 of this chapter, and 
in lieu of the requirements in Sec. Sec.  610.60 and 610.61 of this 
chapter, the following requirements shall be met:
    (1) Final container label--(i) Color coding. The main panel of the 
final container label of all Anti-IgG, -C3d (polyspecific) reagents 
shall be white or colorless and printing shall be solid dark 
contrasting lettering. The main panel of the final container label of 
all other Anti-Human Globulin reagents shall be black with solid white 
lettering. A logo or company name may be placed on the final container 
label; however, the logo or company name shall be located along the 
bottom or end of the label, outside of the main panel.
    (ii) Required information. The proper name ``Anti-Human Globulin'' 
need not appear on the final container label provided the final 
container is distributed in a package and the package label bears the 
proper name. The final container label shall bear the following 
information:
    (A) Name of the antibody or antibodies present as set forth in 
paragraph (a)(4) of this section. Anti-Human Globulin may contain one 
or more antibodies to either immunoglobulins or complement components 
but the name of each significant antibody must appear on the final 
container label (e.g., anti-C3b,

[[Page 38929]]

-C3d, -C4d). The final container labels of polyspecific Anti-Human 
Globulin are not required to identify antibody specificities other than 
anti-IgG and anti-C3d but the reactivity of the Anti-Human Globulin 
shall be accurately described in the package insert.
    (B) Name, address, and license number of the manufacturer.
    (C) Lot number, including any sublot designations.
    (D) Expiration date.
    (E) Source of the product.
    (F) Recommended storage temperature in degrees Celsius.
    (G) Volume of product.
    (H) Appropriate cautionary statement if the Anti-Human Globulin is 
not polyspecific. For example, ``DOES NOT CONTAIN ANTIBODIES TO 
IMMUNOGLOBULINS'' or ``DOES NOT CONTAIN ANTIBODIES TO COMPLEMENT 
COMPONENTS.''
    (I) If the final container is not enclosed in a package, all items 
required for a package label shall appear on the container label.
    (iii) Lettering size. The type size for the designation of the 
specific antibody on the label of a final container shall be not less 
than 12 point, unless otherwise approved by the Director, Center for 
Biologics Evaluation and Research. The prefix anti- and other parts of 
the name such as polyspecific may appear in smaller type.
    (iv) Visual inspection. When the label has been affixed to the 
final container, a sufficient area of the container shall remain 
uncovered for its full length or for no less than 5 millimeters of the 
lower circumference to permit inspection of the contents.
    (2) Package label. The following items shall appear either on the 
package label or on the final container label if see-through packaging 
is used:
    (i) Proper name of the product, and the name of the antibody or 
antibodies as listed in paragraph (a)(4) of this section.
    (ii) Name, address (including ZIP code), and license number of the 
manufacturer.
    (iii) Lot number, including any sublot designations.
    (iv) Expiration date.
    (v) Preservative(s) used and its concentration.
    (vi) Number of containers, if more than one.
    (vii) Recommended storage temperature in degrees Celsius.
    (viii) Source of the product.
    (ix) Reference to enclosed package insert.
    (x) The statement: ``For In Vitro Diagnostic Use.''
    (xi) The statement: ``Meets FDA Potency Requirements.''
    (xii) A statement of an observable indication of an alteration of 
the product, e.g., turbidity, color change, precipitate, that may 
indicate possible deterioration of the product.
    (xiii) Appropriate cautions.
    (3) Package insert. Each final container of Anti-Human Globulin 
shall be accompanied by a package insert meeting the requirements of 
Sec.  809.10 of this chapter. If two or more final containers requiring 
identical package inserts are placed in a single package, only one 
package insert per package is required.
    (4) Names of antibodies. Anti-Human Globulin preparations may 
contain one or more of the antibody specificities listed in this 
paragraph as described in paragraph (a)(1)(ii)(A) of this section.

 
------------------------------------------------------------------------
   Antibody designation on
       container label                         Definition
------------------------------------------------------------------------
(1) Anti-IgG, -C3d;            Contains anti-IgG and anti-C3d (may
 Polyspecific.                  contain other anticomplement and anti-
                                immunoglobulin antibodies).
(2) Anti-IgG.................  Contains anti-IgG with no anti-complement
                                activity (not necessarily gamma chain
                                specific).
(3) Anti-IgG; heavy chains...  Contains only antibodies reactive against
                                human gamma chains.
(4) Anti-C3b.................  Contains only C3b antibodies with no anti-
                                immunoglobulin activity. Note: The
                                antibody produced in response to
                                immunization is usually directed against
                                the antigenic determinant which is
                                located in the C3c subunit; some persons
                                have called this antibody ``anti-C3c.''
                                In product labeling, this antibody
                                should be designated anti-C3b.
(5) Anti-C3d.................  Contains only C3d antibodies with no anti-
                                immunoglobulin activity.
(6) Anti-C4b.................  Contains only C4b antibodies with no anti-
                                immunoglobulin activity.
(7) Anti-C4d.................  Contains only C4d antibodies with no anti-
                                immunoglobulin activity.
------------------------------------------------------------------------

    (b) The applicant may provide the labeling information referenced 
in this section in the form of:
    (1) A symbol accompanied by explanatory text adjacent to the 
symbol;
    (2) A symbol not accompanied by adjacent explanatory text that:
    (i) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the Federal Food, Drug, and Cosmetic 
Act;
    (ii) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (iii) Is explained in a paper or electronic symbols glossary that 
is included in the labeling for the device and the labeling on or 
within the package containing the device bears a prominent and 
conspicuous statement identifying the location of the symbols glossary 
that is written in English or, in the case of articles distributed 
solely in Puerto Rico or in a Territory where the predominant language 
is one other than English, the predominant language may be used; or
    (3) A symbol not accompanied by adjacent explanatory text that:
    (i) Is established in a standard developed by a standards 
development organization (SDO);
    (ii) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) or is contained in a standard that is 
recognized by FDA but is not used according to the specifications for 
use of the symbol set forth in FDA's section 514(c) recognition;
    (iii) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the Federal Food, 
Drug, and Cosmetic Act;
    (iv) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (v) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in

[[Page 38930]]

Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used.
    (c) The use of symbols in device labeling to provide the labeling 
information referenced in paragraph (a) of this section which do not 
meet the requirements of paragraph (b) of this section renders a device 
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic 
Act.
    (d) For purposes of paragraph (b) of this section:
    (1) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (2) The term ``symbols glossary'' means a compiled listing of:
    (i) Each SDO-established symbol used in the labeling for the 
device;
    (ii) The title and designation number of the SDO-developed standard 
containing the symbol;
    (iii) The title of the symbol and its reference number, if any, in 
the standard; and
    (iv) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.

PART 801--LABELING

0
9. The authority citation for part 801 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 
374.


0
10. Amend Sec.  801.15 by revising the section heading and paragraph 
(c)(1) to read as follows:


Sec.  801.15  Medical devices; prominence of required label statements; 
use of symbols in labeling.

* * * * *
    (c)(1)(i) All words, statements, and other information required by 
or under authority of the act to appear on the label or labeling for a 
device shall appear thereon in one or more of the following formats:
    (A) The English language;
    (B) In the case of articles distributed solely in Puerto Rico or in 
a Territory where the predominant language is one other than English, 
the predominant language may be substituted for English;
    (C) A symbol accompanied by adjacent explanatory English text, or 
text in the predominant language of the Territory, in the case of 
articles distributed solely in Puerto Rico or in a Territory where the 
predominant language is one other than English;
    (D) A symbol not accompanied by adjacent explanatory text that:
    (1) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the act;
    (2) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (3) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used;
    (E) A symbol not accompanied by adjacent explanatory text that:
    (1) Is established in a standard developed by a standards 
development organization (SDO);
    (2) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the act or is contained in a 
standard that is recognized by FDA but is not used according to the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition;
    (3) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the act;
    (4) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (5) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used;
    (F) The symbol statement ``Rx only'' or ``[rx] only'' may be used 
as provided under Sec.  801.109(b)(1).
    (ii) The use of symbols in device labeling which do not meet the 
requirements of paragraph (c)(1)(i) of this section renders a device 
misbranded under section 502(c) of the act.
    (iii) For purposes of paragraph (c)(1)(i) of this section:
    (A) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (B) The term ``symbols glossary'' means a compiled listing of:
    (1) Each SDO-established symbol used in the labeling for the 
device;
    (2) The title and designation number of the SDO-developed standard 
containing the symbol;
    (3) The title of the symbol and its reference number, if any, in 
the standard; and
    (4) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.
* * * * *

0
11. Amend Sec.  801.109 by revising paragraph (b)(1) to read as 
follows:


Sec.  801.109  Prescription devices.

* * * * *
    (b) * * *
    (1) The symbol statement ``Rx only'' or ``[rx] only'' or the 
statement ``Caution: Federal law restricts this device to sale by or on 
the order of a ___'', the blank to be filled with the word 
``physician'', ``dentist'', ``veterinarian'', or with the descriptive 
designation of any other practitioner licensed by the law of the State 
in which the practitioner practices to use or order the use of the 
device; and
* * * * *

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

0
12. The authority citation for part 809 continues to read as follows:


[[Page 38931]]


    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 
360i, 360j, 371, 372, 374, 381.


0
13. In Sec.  809.10:
0
a. Add a last sentence to paragraph (a)(4),
0
b. Add a last sentence to paragraph (b)(5)(ii), and
0
c. Add paragraph (g).
    The additions read as follows:


Sec.  809.10  Labeling for in vitro diagnostic products.

    (a) * * *
    (4) * * * The limiting statement appropriate to the intended use of 
a prescription in vitro diagnostic product shall bear the symbol 
statement ``Rx only'' or ``[rx] only'' or the statement ``Caution: 
Federal law restricts this device to sale by or on the order of a 
___'', the blank to be filled with the word ``physician'', ``dentist'', 
``veterinarian'', or with the descriptive designation of any other 
practitioner licensed by the law of the State in which the practitioner 
practices to use or order the use of the device.
* * * * *
    (b) * * *
    (5) * * *
    (ii) * * * The limiting statement appropriate to the intended use 
of a prescription in vitro diagnostic product shall bear the symbol 
statement ``Rx only'' or ``[rx] only'' or the statement ``Caution: 
Federal law restricts this device to sale by or on the order of a 
___'', the blank to be filled with the word ``physician'', ``dentist'', 
``veterinarian'', or with the descriptive designation of any other 
practitioner licensed by the law of the State in which the practitioner 
practices to use or order the use of the device.
* * * * *
    (g)(1) The applicant may provide the labeling information 
referenced in this section in the form of:
    (i) A symbol accompanied by explanatory text adjacent to the 
symbol;
    (ii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the act;
    (B) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (C) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used;
    (iii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is established in a standard developed by a standards 
development organization (SDO);
    (B) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the act or is contained in a 
standard that is recognized by FDA but is not used according to the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition;
    (C) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the act;
    (D) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (E) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used; or
    (iv) The symbol statement ``Rx only'' or ``[rx] only'' used as 
provided under paragraphs (a)(4) and (b)(5)(ii) of this section.
    (2) The use of symbols in device labeling which do not meet the 
requirements of paragraph (g)(1) of this section renders a device 
misbranded under section 502(c) of the act.
    (3) For purposes of paragraph (g)(1) of this section:
    (i) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation 
is balanced, where an appeals process is included, where the standard 
is not in conflict with any statute, regulation, or policy under which 
FDA operates, and where the standard is national or international in 
scope.
    (ii) The term ``symbols glossary'' means a compiled listing of:
    (A) Each SDO-established symbol used in the labeling for the 
device;
    (B) The title and designation number of the SDO-developed standard 
containing the symbol;
    (C) The title of the symbol and its reference number, if any, in 
the standard; and
    (D) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set 
forth in FDA's section 514(c) recognition, the explanatory text as 
provided in the standard.

    Dated: June 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13989 Filed 6-14-16; 8:45 am]
BILLING CODE 4164-01-P