Unique Device Identification System, 69393-69399 [2012-28015]
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Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Proposed Rules
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[FR Doc. 2012–27999 Filed 11–16–12; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
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[Docket No. FDA–2011–N–0090]
RIN 0910–AG31
Unique Device Identification System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule; amendment.
The Food and Drug
Administration (FDA) is amending its
SUMMARY:
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July 10, 2012, proposed rule (77 FR
40736) to establish a unique device
identification system as required by
recent amendments to the Federal Food,
Drug, and Cosmetic Act (the FD&C Act).
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
Act (FDASIA) was signed into law;
section 614 of FDASIA amends the
FD&C Act in ways that require
modification of the timeframe for
implementation of the proposed rule’s
requirements as they apply to devices
that are implantable, life-saving (lifesupporting), or life-sustaining.
DATES: Submit either electronic or
written comments on the amendment to
the Proposed Rule by December 19,
2012. See section VII for the proposed
effective dates of a final rule based on
the amended proposed rule.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2011–N–
0090 and/or RIN Number 0910–AG31,
by any of the following methods.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (For
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name, Docket
Number, and Regulatory Information
Number (RIN) for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jay
Crowley, Center for Devices and
Radiological Health, Food and Drug
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69393
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–5995, email: cdrhudi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, FDASIA was signed
into law (Pub. L. 112–144). On July 10,
2012, FDA published a proposed rule to
establish a unique device identification
system, as required by section 519(f) of
the FD&C Act (21 U.S.C. 360i(f)).
Section 614 of FDASIA amends section
519(f) of the FD&C Act in ways that
require modification of the timeframe
for implementation of the proposed
rule’s requirements as they apply to
devices that are implantable, life-saving
(life-supporting), or life-sustaining. This
document explains how FDA is
amending the July 10, 2012, proposed
rule to meet the requirements of
amended section 519(f) of the FD&C
Act.
II. Description of the Proposed Rule
A. FDA’s July 10, 2012, Proposed Rule
Our July 10, 2012, document provides
a detailed description of the proposed
rule. The proposed rule includes unique
device identifier (UDI) labeling
requirements (proposed for inclusion in
21 CFR part 801), requirements relating
to issuing Agencies and submission of
data to the Global Unique Device
Identification Database (GUDID)
(proposed new part 830), and
conforming amendments to several
existing FDA regulations. FDA proposed
a phased implementation of the rule’s
requirements, with some requirements
going into effect immediately after
publication of a final rule, and other
requirements going into effect 1 year, 3
years, 5 years, and 7 years after
publication of a final rule. This phased
implementation is summarized in the
July 10, 2012, proposed rule by Table
7—Effective Dates of UDI Regulatory
Requirements (77 FR 40736 at 40764).
B. Changes Required by the Enactment
of FDASIA
Section 614 of FDASIA amends
section 519(f) of the FD&C Act, the
provision that requires FDA to establish
a unique device identification system.
Prior to the enactment of FDASIA,
section 519(f) of the FD&C Act did not
specify the date by which a proposed
rule is required, did not identify any
particular devices as requiring
expedited implementation of UDI
requirements, and did not specify
timeframes for publication of a final
rule. The FDASIA amendments to
section 519(f) address each of those
points. As amended by FDASIA, section
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519(f) of the FD&C Act now requires
that not later than December 31, 2012,
the Secretary shall issue proposed
regulations establishing a unique device
identification system for medical
devices requiring the label of devices to
bear a unique identifier, unless the
Secretary requires an alternative
placement or provides an exception for
a particular device or type of device.
The unique identifier shall adequately
identify the device through distribution
and use, and may include information
on the lot or serial number. Section
519(f) of the FD&C Act also requires that
the Secretary shall finalize the proposed
regulations not later than 6 months after
the close of the comment period and
shall implement the final regulations
with respect to devices that are
implantable, life-saving, and life
sustaining not later than 2 years after
the regulations are finalized, taking into
account patient access to medical
devices and therapies.
The change that has prompted
amendment of FDA’s proposed rule is
the provision in the final sentence that
requires ‘‘final regulations with respect
to devices that are implantable, lifesaving, and life sustaining’’ to be
implemented within 2 years of
finalization of the rule. (We refer to
‘‘life-saving’’ devices as ‘‘lifesupporting,’’ as explained later in this
document.). Thus we are amending our
July 10, 2012, proposed rule by
changing some of the proposed effective
dates for requirements applicable to
implantable, life-supporting, and lifesustaining devices, so that the
requirements applicable to these devices
will be effective no later than 2 years
from finalization of the rule.
Under our July 10, 2012, proposed
rule, all class III devices and all devices
licensed under the Public Health
Service Act (PHS Act) (42 U.S.C. 262)
would be required to bear a UDI within
1 year of the date we publish a final
rule; thus, this effective date does not
need to be changed. Pursuant to
amended section 519(f) of the FD&C
Act, we are now proposing to require all
other implantable, life-supporting, and
life-sustaining devices (i.e., those that
are not already subject to the 1-year
effective date) to bear a UDI within 2
years following the publication of a final
rule. (See proposed § 801.20(b)(2) as
amended by this document.) Under our
July 10, 2012, proposed rule, when a
device is required to be labeled with a
UDI, proposed § 830.300 would require
the labeler of that device to submit
information concerning the device to
the GUDID. Consequently, the labelers
of all implantable, life-supporting, and
life-sustaining devices will be required
to submit data to the GUDID within 2
years of the date we publish a final rule;
see proposed § 801.20(b)(1) and (b)(2) as
amended by this document.
Proposed § 801.50 would require
direct marking of the UDI on the device
itself for implantable devices, devices
intended to be used more than once and
that are intended to be sterilized before
each use, and stand-alone software. We
are now amending the proposed rule so
that any such devices that fall into the
categories specified by revised section
519(f) of the FD&C Act—devices that are
implantable, life supporting, or life
sustaining—would have to comply with
§ 801.50, establishing a system of
unique device identification 2 years
after publication of a final rule. FDA
believes that the only devices subject to
direct marking that fit within the device
categories expressly referred to in
revised section 519(f) of the FD&C Act
are implantable devices and is assuming
only implantable devices will be
affected by the revised implementation
date for the direct marking requirement.
We welcome comments on whether any
devices subject to the direct marking
requirement under proposed § 801.50
other than implantable devices fit
within the device categories in amended
section 519(f) of the FD&C Act.
FDA interprets ‘‘life-saving’’ in
section 519(f) of the FD&C Act, as
amended by section 614 of FDASIA, to
have the same meaning as ‘‘lifesupporting’’ in other device provisions
of the FD&C Act. Section 614 of FDASIA
refers to devices that are ‘‘implantable,
life-saving, and life-sustaining.’’ The
device provisions of the FD&C Act do
not use the term ‘‘life-saving’’ in any
other instance, but in several instances
refer to devices that are ‘‘implantable,
life sustaining, or life supporting.’’ (See
section 513(a) of the FD&C Act (21
U.S.C. 360c(a)) (definitions of class II
and class III devices); section 519
(records and reports on devices,
including adverse event reporting and
device tracking); section 522 of the
FD&C Act (21 U.S.C. 360l) (postmarket
surveillance); and section 523 of the
FD&C Act (21 U.S.C. 360m) (accredited
persons).) In order for the language of
our proposed UDI rule to be consistent
with existing FDA regulations and the
other provisions of the FD&C Act, in the
amendments to the proposed
regulations we use the term ‘‘lifesupporting’’ instead of ‘‘life-saving.’’
FDA, the medical device industry, and
the health care community are already
familiar with the term ‘‘life-supporting’’
as applied to medical devices, which
will facilitate FDA’s implementation of
the amended proposed rule.
A list of product codes for devices
that FDA considers to be implantable,
life-saving, and life-sustaining for
purposes of section 614 of FDASIA,
amending section 519(f) of the FD&C
Act, is available in docket FDA–2011–
N–0090 (Ref. 12).
FDA is not extending the comment
period of the proposed rule, which
closed on November 7, 2012. We do not
believe that amending some of the
proposed effective dates for certain
categories of devices necessitates
additional time to review the amended
proposed rule and to submit comments
to FDA.
C. How the Amendments Made by This
Proposed Rule Will Affect the July 10,
2012, Proposed Rule
These amendments affect only
implantable, life-supporting, or lifesustaining devices. With the exception
of the change to the proposed effective
date for the direct marking requirement,
these amendments do not affect class III
devices or devices licensed under the
PHS Act because such devices would
have to bear a UDI within 1 year of
finalization under the July 10, 2012,
proposed rule.
We are updating Table 7—Effective
Dates of UDI Regulatory Requirements,
of the July 10, 2012, proposed rule to
reflect the revisions provided by this
document; we have also corrected two
citations within the table (citations to
§ 830.320 should have cited § 830.300).
Updated table 7 appears in this
document in section VI. Updated
Proposed Effective Dates.
New table 8 of this document
summarizes the effects of the
amendments we are making to the July
10, 2012, proposed rule.
TABLE 8—EFFECTS OF THE AMENDMENTS TO THE JULY 10, 2012, PROPOSED RULE
Category of device
Effect of amendments to proposed rule
Class III implantable, life-supporting, and life-sustaining devices, and
implantable, life-supporting, and life-sustaining devices licensed
under the PHS Act.
No effect with respect to proposed requirement for device to bear UDI
on the label and device package or proposed requirements for submission of data to the GUDID.
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TABLE 8—EFFECTS OF THE AMENDMENTS TO THE JULY 10, 2012, PROPOSED RULE—Continued
Category of device
Effect of amendments to proposed rule
Class II implantable, life-supporting, and life-sustaining devices ............
Class I implantable, life-supporting, and life-sustaining devices, and
implantable, life-supporting, and life-sustaining devices that have not
been classified into class I, II, or III.
Implantable devices would have to bear a UDI as a permanent marking
on the device itself 1 year earlier than first proposed.
Would have to bear a UDI on the label and device package and submit
data to the GUDID 1 year earlier than first proposed.
Implantable devices would have to bear a UDI as a permanent marking
on the device itself 3 years earlier than first proposed.
Would have to bear a UDI on the label and device package and submit
data to the GUDID 3 years earlier than first proposed.
Implantable devices would have to bear a UDI as a permanent marking
on the device itself 5 years earlier than first proposed.
D. Request for Comments
This amendment announces changes
to the proposed rule required by
FDASIA. The comment period on the
proposed rule closed on November 7,
2012. We request comments only on the
changes discussed in this amendment to
the proposed rule and may decline to
consider other comments submitted to
this docket.
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III. Legal Authority for the Proposed
Rule
Section 226 of the Food and Drug
Administration Amendments Act (Pub.
L. 110–85) (2007), amended the FD&C
Act by adding a new section 519(f). This
section provides for FDA to issue
regulations establishing a unique device
identification system for medical
devices. In addition, section 510(e) of
the FD&C Act (21 U.S.C. 360(e))
authorizes FDA to issue regulations to
‘‘prescribe a uniform system for
identification of devices’’ and to require
persons to ‘‘list such devices in
accordance with such system.’’
Therefore, FDA is issuing the provisions
of this proposed rule that would
establish a unique device identification
system under sections 510(e), 519(f),
and 701(a) (21 U.S.C. 371(a)) of the
FD&C Act (which provides FDA the
authority to issue regulations for the
efficient enforcement of the FD&C Act).
Devices for which there has been a
failure or refusal to furnish any material
or information required by or under
section 519 of the FD&C Act respecting
the device are misbranded under section
502(t)(2) of the FD&C Act (21 U.S.C.
352(t)(2)). The failure or refusal to
furnish any material or information
required by or under section 519 of the
FD&C Act is a prohibited act under
section 301(q)(1)(B) of the FD&C Act (21
U.S.C. 331(q)(1)(B)).
Section 701(a) of the FD&C Act gives
FDA the authority to issue regulations
for the efficient enforcement of the
FD&C Act. By requiring a UDI to appear
on the label of devices, and by
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establishing the GUDID, the proposed
rule is designed to improve the accuracy
and precision of adverse event
reporting, as required by section 519(a)
and (b) of the FD&C Act, which will
enable FDA to more quickly and
precisely identify device problems, such
as safety and/or effectiveness concerns.
Once a problem is identified, whether
through improved reporting or
otherwise, the presence of the UDI on
the device label, packaging, in certain
cases directly marked on the device
itself, and in the GUDID will enable
FDA to more efficiently and effectively
respond, and protect the public health
by addressing the problem using one or
more of the regulatory tools that
Congress has provided for this purpose,
such as notification or mandatory recall
under section 518 of the FD&C Act (21
U.S.C. 360h), tracking under section
519(e) of the FD&C Act, ensuring the
adequacy of a voluntary recall with the
assistance of reports of corrections and
removals as required by section 519(g)
of the FD&C Act, or seizing a device that
is adulterated under section 501 of the
FD&C Act (21 U.S.C. 351) and/or
misbranded under section 502 of the
FD&C Act. Thus, these provisions of the
proposed rule are issued under the
authority of these sections in addition to
the broad authority of section 519(f) of
the FD&C Act.
Section 510(j) of the FD&C Act
requires listing information to be
accompanied by, at minimum, the label,
package insert, and a representative
sampling of any other labeling for the
device (see section 510(j)(1)(B)(ii)). For
certain categories of devices, all labeling
must be submitted (see section
510(j)(1)(A) and (j)(1)(B)(i) of the FD&C
Act). We expect most of the information
that would be required to be submitted
to the GUDID (see proposed § 830.310),
is information that appears on the
device label or in the package insert,
and is included in the information that
is required to be submitted to FDA by
section 510(j) of the FD&C Act.
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The provisions of the proposed rule
that would require UDIs to be included
in various records and reports, allow the
use of UDIs to identify devices subject
to reports of corrections and removals
and records of corrections of removals
that are not required to be reported to
FDA, and require reporting of UDIs in
periodic reports for class III devices, are
issued under the authority of sections
519 and 701(a) of the FD&C Act.
The provisions of the proposed rule
that would amend the Quality System
Regulation by requiring examination of
the accuracy of the UDI as part of the
scope of the labeling inspection, that the
device history record include any UDI
or universal product code (UPC), that
complaint records include any UDI or
UPC, and that the service report include
an UDI or UPC, are issued under
sections 520(f) (21 U.S.C. 360j(f)) and
701(a) of the FD&C Act.
The provisions of the proposed rule
that would require the inclusion of UDIs
on reports regarding tracked devices is
authorized by sections 519(e) and 701(a)
of the FD&C Act.
The provision of the proposed rule
that would require that postmarket
surveillance plans submitted to FDA
include the device identifier of the
devices involved is issued under
sections 522 (21 U.S.C. 360l), and 701(a)
of the FD&C Act.
Finally, the changes in proposed
effective dates for devices that are
implantable, life-saving, and life
sustaining, are pursuant to the changes
to section 519(f) of the FD&C Act made
by section 614 of FDASIA.
IV. Analysis of Impacts
Our July 10, 2012, document
summarizes the analysis of impacts of
the proposed rule. The full analysis of
impacts and findings that are presented
in Preliminary Regulatory Impact
Analysis (RIA) of the proposed rule
remain unchanged (Ref. 10 of the July
10, 2012, proposed rule). However, we
are amending our summary of costs to
include the FDASIA requirement to
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incorporate the revised implementation
date of 2 years for devices that are
implantable, life-supporting, and lifesustaining. The July 10, 2012, RIA and
the Addendum to the RIA (new Ref. 13)
are available at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/
ucm309815.htm.
We lack sufficient information to
estimate the number of establishments
that label life-supporting and lifesustaining devices and would be
affected by the FDASIA requirement.
Therefore, for this amended cost
summary, we make a simplifying
assumption that labelers of all class II
devices would comply with the UDI
requirements in year 2 instead of year 3
as initially specified under the proposed
rule. Because the modified timeframe
would advance the implementation date
to directly mark implantable, lifesupporting, and life-sustaining devices,
we assume that labelers of class III
devices that are implants would comply
with the direct marking requirements in
year 2 instead of year 3 as initially
specified under the proposed rule. The
effect of these simplifying assumptions
might be to overstate the annualized
costs for some labelers of class II devices
that are not considered life-supporting
or life-sustaining devices, and to
underestimate the annualized costs for
some labelers of class I devices that are
considered life-supporting or lifesustaining devices.
The amended summary of the total
costs of the proposed rule for all sectors
is presented in the updated table 3 of
this document. The total present value
of domestic costs for all affected sectors
would be about $554.8 million over 10
years with a 7 percent discount rate and
$625.4 million at 3 percent. The total
annualized costs over 10 years would be
$73.8 million at 7 percent and $71.1
million at 3 percent. The total increase
in annualized costs to domestic labelers
compared to the proposed rule is about
$5.4 million at 7 percent over 10 years.
UPDATED TABLE 3—SUMMARY OF THE ESTIMATED REGULATORY COSTS OF THE PROPOSED RULE
[2010 dollars] 1 2
Total present value of cost over 10
years
($ million)
Affected sectors
Total annualized costs over 10 years
($ million)
3 Percent
7 Percent
3 Percent
7 Percent
Domestic Labelers ...............................................................
Issuing Agencies ..................................................................
FDA ......................................................................................
Imports .................................................................................
$608.3 ...................
$1.0 .......................
$16.1 .....................
Not quantified .......
$540.2 ...................
$0.9 .......................
$13.7 .....................
Not quantified .......
$69.2 .....................
$0.1 .......................
$1.8 .......................
Not quantified .......
$71.9.
$0.1.
$1.8.
Not quantified.
Total Domestic Cost of the Proposed Rule .................
$625.4 ...................
$554.8 ...................
$71.1 .....................
$73.8.
1 Present
value and annualized costs calculated at the beginning of the period.
costs for labelers are revised to reflect FDASIA requirement that labelers of affected devices comply in year 2. However, FDA’s revised estimate assumes that all class II devices would comply in year 2.
2 Domestic
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Updated table 1 (and identical
updated table 4 of the proposed rule)
presents the Regulatory Information
Service Center (RISC) and Office of
Information and Regulatory Affairs
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(OIRA) Combined Information System
(ROCIS) accounting information under
the assumption that labelers of all class
II devices would comply with the UDI
requirements in year 2 and that all
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labelers of class II implantable devices
would comply with the direct marking
requirements in year 2.
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The updates made by this proposed
rule do not affect the estimate we
previously provided regarding our July
10, 2012, proposed rule.
In accordance with section 3507(d) of
the PRA (44 U.S.C. 3501 et seq.), the
information collection or recordkeeping
requirements included in this proposed
rule have been submitted for approval to
OMB. A copy of the supporting
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statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain
(OMB Number 0910–0720) and is
posted to the docket at https://
www.regulations.gov, in docket FDA–
2011–N–0090 (Ref. 11 of the proposed
rule).
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.
VI. Environmental Impact
FDA has determined under 21 CFR
25.30(h) that this action is of a type that
FDA updates Table 7—Effective Dates
of UDI Regulatory Requirements, in our
July 10, 2012, proposed rule as follows.
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VII. Updated Proposed Effective Dates
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V. Information Collection Requirements
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UPDATED TABLE 7—EFFECTIVE DATES OF UDI REGULATORY REQUIREMENTS
Effective date
Immediately upon publication of a final rule.
One year after publication of
a final rule.
Two years after publication
of a final rule.
Three years after publication
of a final rule.
Five years after publication
of a final rule.
Seven years after publication of a final rule.
90 days after publication of
a final rule.
Requirement
Requests for an exception or alternative to UDI labeling requirements may be submitted pursuant to § 801.35.
§§ 830.100–830.130 (subpart C of part 830, concerning accreditation of issuing Agencies) and § 830.10 (incorporation by reference of certain standards) go into effect. This will allow applications for accreditation as an
issuing Agency to be submitted to FDA immediately.
Dates on medical device labels must be formatted as required by § 801.18.
The label and package of class III medical devices and devices licensed under the PHS Act must bear a UDI.
§ 801.20(b)(1).
Data for class III devices and devices licensed under the PHS Act that are required to be labeled with a UDI must
be submitted to the GUDID data base. § 830.300.
The label and package of implantable, life-supporting, and life-sustaining devices that are not class III devices or
licensed under the PHS Act must bear a UDI. § 801.20(b)(2).
Data for implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the
PHS Act and that are required to be labeled with a UDI, must be submitted to the GUDID data base. § 830.300.
All implantable devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device
itself. § 801.50.
Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if
the device is (1) a device intended to be used more than once and intended to be sterilized before each use, or
(2) stand-alone software regulated as a medical device. § 801.50.
The label and package of class II medical devices must bear a UDI. § 801.20(b)(3).
Data for class II devices that are required to be labeled with a UDI, must be submitted to the GUDID data base.
§ 830.300.
Class II devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if
the device is (1) a device intended to be used more than once and intended to be sterilized before each use, or
(2) stand-alone software regulated as a medical device. § 801.50.
The label and package of class I medical devices and devices that have not been classified into class I, class II,
or class III must bear a UDI. § 801.20(b)(4), (5).
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID data base. § 830.300.
Class I devices and devices that have not been classified into class I, class II, or class III required to be labeled
with a UDI must a bear UDI as a permanent marking on the device itself if the device is (1) a device intended
to be used more than once and intended to be sterilized before each use, or (2) stand-alone software regulated
as a medical device. § 801.50.
All other provisions go into effect, although some will have no practical effect until other provisions listed in this
table go into effect.
VIII. Federalism
pmangrum on DSK3VPTVN1PROD with PROPOSALS-1
FDA has analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. FDA
has determined that the proposed rule,
if finalized, would not contain policies
that would 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, the Agency tentatively
concludes that the proposed 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.
IX. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
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13:53 Nov 16, 2012
Jkt 229001
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
X. References
We have not removed any references
listed in the July 10, 2012, proposed
rule. We are adding new references 12
and 13 to account for the additional
costs attributable to the FDASIA
amendment of section 519(f) of the
FD&C Act, specifically the requirement
that FDA must implement the regulation
with respect to devices that are
implantable, life-supporting, and lifesustaining not later than 2 years after we
publish a final rule.
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
12. List of medical devices, by
product code, that FDA considers to be
implantable, life-saving, and lifesustaining for purposes of section 614 of
FDASIA, amending section 519(f) of the
FD&C Act, November 2012.
13. Addendum to the Preliminary
Regulatory Impact Analysis of the
Proposed Rule to Require a Unique
Device Identification System, Docket
No. FDA–2011–N–0090.
List of Subjects in 21 CFR Part 801
Labeling, Medical devices, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321
et seq., as amended) and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 801, as proposed to be
amended in the Federal Register of July
10, 2012 (77 FR 40736), be further
amended as follows:
PART 801—LABELING
1. The authority citation for part 801
continues to read as follows:
E:\FR\FM\19NOP1.SGM
19NOP1
Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Proposed Rules
Authority: 21 U.S.C. 321, 331, 351, 352,
360i, 360j, 371, 374.
Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
DATES:
[FR Doc. 2012–28015 Filed 11–16–12; 8:45 am]
Subpart B—[Amended]
ADDRESSES:
2. Revise § 801.20(b) to read as
follows:
BILLING CODE 4160–01–P
§ 801.20 Label to bear a unique device
identifier (UDI).
ENVIRONMENTAL PROTECTION
AGENCY
*
*
*
*
*
(b) Effective dates. The requirements
of paragraph (a) of this section become
effective:
(1) If the device is a class III medical
device or is a device licensed under
section 351 of the Public Health Service
Act, as amended, 5 U.S.C. 262, [A DATE
WILL BE ADDED THAT IS 1 YEAR
AFTER DATE OF PUBLICATION OF
THE FINAL RULE IN THE Federal
Register];
(2) If the device is an implantable,
life-supporting, or life-sustaining
device, and is not a class III device or
a device licensed under section 351 of
the Public Health Service Act, as
amended, 5 U.S.C. 262, [A DATE WILL
BE ADDED THAT IS 2 YEARS AFTER
DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register];
(3) If the device is a class II medical
device not covered by paragraph (2), [A
DATE WILL BE ADDED THAT IS 3
YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE
IN THE Federal Register];
(4) If the device is a class I medical
device not covered by paragraph (2), [A
DATE WILL BE ADDED THAT IS 5
YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE
IN THE Federal Register];
(5) If the device is not classified into
class I, II, or III, [A DATE WILL BE
ADDED THAT IS 5 YEARS AFTER
DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register].
*
*
*
*
*
3. Revise § 801.50(d) to read as
follows:
§ 801.50 Devices that must be directly
marked with a unique device identifier.
pmangrum on DSK3VPTVN1PROD with PROPOSALS-1
*
*
*
*
*
(d) Effective dates. The requirements
of this section apply to a device that is
an implantable, life-supporting, or lifesustaining device [A DATE WILL BE
ADDED THAT IS 2 YEARS AFTER
DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register],
and to any other device 2 years after the
date that applies to the device under
§ 801.20(b).
*
*
*
*
*
VerDate Mar<15>2010
13:53 Nov 16, 2012
Jkt 229001
69399
40 CFR Part 52
[EPA–R03–OAR–2010–0141; FRL–9752–8]
Approval and Promulgation of Air
Quality Implementation Plans;
Delaware; Attainment Plan for the
Philadelphia-Wilmington,
Pennsylvania-New Jersey-Delaware
1997 Fine Particulate Matter
Nonattainment Area
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
a State Implementation Plan (SIP)
revision submitted by Delaware on
April 3, 2008, as amended on April 25,
2012. The SIP revision demonstrates
attainment of the 1997 annual fine
particulate matter (PM2.5) national
ambient air quality standard (NAAQS)
for the Philadelphia-Wilmington,
Pennsylvania-New Jersey-Delaware
(PA–NJ–DE) nonattainment area
(Philadelphia Area). This Delaware SIP
revision (herein called the ‘‘attainment
plan’’) includes the Philadelphia Area’s
attainment demonstration and motor
vehicle emission budgets (MVEBs) used
for transportation conformity purposes
for New Castle County in Delaware. The
attainment plan also includes an
analysis of reasonably available control
measures (RACM) and reasonably
available control technology (RACT), a
base year emissions inventory, and
contingency measures. The April 25,
2012 submittal is a SIP revision that
replaces the MVEBs in the April 3, 2008
submittal with a budget that is based on
the Motor Vehicle Emissions Simulator
(MOVES) model. In a separate and
concurrent process, EPA is conducting a
procedure to find adequate the MVEBs
for New Castle County. Furthermore,
EPA has determined that a reasonable
further progress (RFP) plan is not
required because Delaware projected
that attainment of the 1997 annual PM2.5
NAAQS occurred in the Philadelphia
Area by the attainment date of April
2010. This action is being taken in
accordance with the Clean Air Act
(CAA) and the Clean Air Fine
Particulate Implementation Rule (PM2.5
Implementation Rule) published on
April 25, 2007.
SUMMARY:
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
Written comments must be
received on or before December 19,
2012.
Submit your comments,
identified by Docket ID Number EPA–
R03–OAR–2010–0141 by one of the
following methods:
A. www.regulations.gov. Follow the
on-line instructions for submitting
comments.
B. Email: mastro.donna@epa.gov.
C. Mail: EPA–R03–OAR–2010–0141,
Donna Mastro, Acting Associate
Director, Office of Air Planning
Program, Mailcode 3AP30, U.S.
Environmental Protection Agency,
Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
D. Hand Delivery: At the previouslylisted EPA Region III address. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–R03–OAR–2010–
0141. EPA’s policy is that all comments
received will be included in the public
docket without change, and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or email. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an email
comment directly to EPA without going
through www.regulations.gov, your
email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the
electronic docket are listed in the
www.regulations.gov index. Although
listed in the index, some information is
E:\FR\FM\19NOP1.SGM
19NOP1
]]>Agencies
[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Proposed Rules]
[Pages 69393-69399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28015]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[Docket No. FDA-2011-N-0090]
RIN 0910-AG31
Unique Device Identification System
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its July
10, 2012, proposed rule (77 FR 40736) to establish a unique device
identification system as required by recent amendments to the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food
and Drug Administration Safety and Innovation Act (FDASIA) was signed
into law; section 614 of FDASIA amends the FD&C Act in ways that
require modification of the timeframe for implementation of the
proposed rule's requirements as they apply to devices that are
implantable, life-saving (life-supporting), or life-sustaining.
DATES: Submit either electronic or written comments on the amendment to
the Proposed Rule by December 19, 2012. See section VII for the
proposed effective dates of a final rule based on the amended proposed
rule.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0090 and/or RIN Number 0910-AG31, by any of the following methods.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Fax: 301-827-6870.
Mail/Hand delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency
name, Docket Number, and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
https://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-5995, email:
cdrhudi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, FDASIA was signed into law (Pub. L. 112-144). On
July 10, 2012, FDA published a proposed rule to establish a unique
device identification system, as required by section 519(f) of the FD&C
Act (21 U.S.C. 360i(f)). Section 614 of FDASIA amends section 519(f) of
the FD&C Act in ways that require modification of the timeframe for
implementation of the proposed rule's requirements as they apply to
devices that are implantable, life-saving (life-supporting), or life-
sustaining. This document explains how FDA is amending the July 10,
2012, proposed rule to meet the requirements of amended section 519(f)
of the FD&C Act.
II. Description of the Proposed Rule
A. FDA's July 10, 2012, Proposed Rule
Our July 10, 2012, document provides a detailed description of the
proposed rule. The proposed rule includes unique device identifier
(UDI) labeling requirements (proposed for inclusion in 21 CFR part
801), requirements relating to issuing Agencies and submission of data
to the Global Unique Device Identification Database (GUDID) (proposed
new part 830), and conforming amendments to several existing FDA
regulations. FDA proposed a phased implementation of the rule's
requirements, with some requirements going into effect immediately
after publication of a final rule, and other requirements going into
effect 1 year, 3 years, 5 years, and 7 years after publication of a
final rule. This phased implementation is summarized in the July 10,
2012, proposed rule by Table 7--Effective Dates of UDI Regulatory
Requirements (77 FR 40736 at 40764).
B. Changes Required by the Enactment of FDASIA
Section 614 of FDASIA amends section 519(f) of the FD&C Act, the
provision that requires FDA to establish a unique device identification
system. Prior to the enactment of FDASIA, section 519(f) of the FD&C
Act did not specify the date by which a proposed rule is required, did
not identify any particular devices as requiring expedited
implementation of UDI requirements, and did not specify timeframes for
publication of a final rule. The FDASIA amendments to section 519(f)
address each of those points. As amended by FDASIA, section
[[Page 69394]]
519(f) of the FD&C Act now requires that not later than December 31,
2012, the Secretary shall issue proposed regulations establishing a
unique device identification system for medical devices requiring the
label of devices to bear a unique identifier, unless the Secretary
requires an alternative placement or provides an exception for a
particular device or type of device. The unique identifier shall
adequately identify the device through distribution and use, and may
include information on the lot or serial number. Section 519(f) of the
FD&C Act also requires that the Secretary shall finalize the proposed
regulations not later than 6 months after the close of the comment
period and shall implement the final regulations with respect to
devices that are implantable, life-saving, and life sustaining not
later than 2 years after the regulations are finalized, taking into
account patient access to medical devices and therapies.
The change that has prompted amendment of FDA's proposed rule is
the provision in the final sentence that requires ``final regulations
with respect to devices that are implantable, life-saving, and life
sustaining'' to be implemented within 2 years of finalization of the
rule. (We refer to ``life-saving'' devices as ``life-supporting,'' as
explained later in this document.). Thus we are amending our July 10,
2012, proposed rule by changing some of the proposed effective dates
for requirements applicable to implantable, life-supporting, and life-
sustaining devices, so that the requirements applicable to these
devices will be effective no later than 2 years from finalization of
the rule.
Under our July 10, 2012, proposed rule, all class III devices and
all devices licensed under the Public Health Service Act (PHS Act) (42
U.S.C. 262) would be required to bear a UDI within 1 year of the date
we publish a final rule; thus, this effective date does not need to be
changed. Pursuant to amended section 519(f) of the FD&C Act, we are now
proposing to require all other implantable, life-supporting, and life-
sustaining devices (i.e., those that are not already subject to the 1-
year effective date) to bear a UDI within 2 years following the
publication of a final rule. (See proposed Sec. 801.20(b)(2) as
amended by this document.) Under our July 10, 2012, proposed rule, when
a device is required to be labeled with a UDI, proposed Sec. 830.300
would require the labeler of that device to submit information
concerning the device to the GUDID. Consequently, the labelers of all
implantable, life-supporting, and life-sustaining devices will be
required to submit data to the GUDID within 2 years of the date we
publish a final rule; see proposed Sec. 801.20(b)(1) and (b)(2) as
amended by this document.
Proposed Sec. 801.50 would require direct marking of the UDI on
the device itself for implantable devices, devices intended to be used
more than once and that are intended to be sterilized before each use,
and stand-alone software. We are now amending the proposed rule so that
any such devices that fall into the categories specified by revised
section 519(f) of the FD&C Act--devices that are implantable, life
supporting, or life sustaining--would have to comply with Sec. 801.50,
establishing a system of unique device identification 2 years after
publication of a final rule. FDA believes that the only devices subject
to direct marking that fit within the device categories expressly
referred to in revised section 519(f) of the FD&C Act are implantable
devices and is assuming only implantable devices will be affected by
the revised implementation date for the direct marking requirement. We
welcome comments on whether any devices subject to the direct marking
requirement under proposed Sec. 801.50 other than implantable devices
fit within the device categories in amended section 519(f) of the FD&C
Act.
FDA interprets ``life-saving'' in section 519(f) of the FD&C Act,
as amended by section 614 of FDASIA, to have the same meaning as
``life-supporting'' in other device provisions of the FD&C Act. Section
614 of FDASIA refers to devices that are ``implantable, life-saving,
and life-sustaining.'' The device provisions of the FD&C Act do not use
the term ``life-saving'' in any other instance, but in several
instances refer to devices that are ``implantable, life sustaining, or
life supporting.'' (See section 513(a) of the FD&C Act (21 U.S.C.
360c(a)) (definitions of class II and class III devices); section 519
(records and reports on devices, including adverse event reporting and
device tracking); section 522 of the FD&C Act (21 U.S.C. 360l)
(postmarket surveillance); and section 523 of the FD&C Act (21 U.S.C.
360m) (accredited persons).) In order for the language of our proposed
UDI rule to be consistent with existing FDA regulations and the other
provisions of the FD&C Act, in the amendments to the proposed
regulations we use the term ``life-supporting'' instead of ``life-
saving.'' FDA, the medical device industry, and the health care
community are already familiar with the term ``life-supporting'' as
applied to medical devices, which will facilitate FDA's implementation
of the amended proposed rule.
A list of product codes for devices that FDA considers to be
implantable, life-saving, and life-sustaining for purposes of section
614 of FDASIA, amending section 519(f) of the FD&C Act, is available in
docket FDA-2011-N-0090 (Ref. 12).
FDA is not extending the comment period of the proposed rule, which
closed on November 7, 2012. We do not believe that amending some of the
proposed effective dates for certain categories of devices necessitates
additional time to review the amended proposed rule and to submit
comments to FDA.
C. How the Amendments Made by This Proposed Rule Will Affect the July
10, 2012, Proposed Rule
These amendments affect only implantable, life-supporting, or life-
sustaining devices. With the exception of the change to the proposed
effective date for the direct marking requirement, these amendments do
not affect class III devices or devices licensed under the PHS Act
because such devices would have to bear a UDI within 1 year of
finalization under the July 10, 2012, proposed rule.
We are updating Table 7--Effective Dates of UDI Regulatory
Requirements, of the July 10, 2012, proposed rule to reflect the
revisions provided by this document; we have also corrected two
citations within the table (citations to Sec. 830.320 should have
cited Sec. 830.300). Updated table 7 appears in this document in
section VI. Updated Proposed Effective Dates.
New table 8 of this document summarizes the effects of the
amendments we are making to the July 10, 2012, proposed rule.
Table 8--Effects of the Amendments to the July 10, 2012, Proposed Rule
------------------------------------------------------------------------
Effect of amendments to
Category of device proposed rule
------------------------------------------------------------------------
Class III implantable, life-supporting, No effect with respect to
and life-sustaining devices, and proposed requirement for
implantable, life-supporting, and life- device to bear UDI on the
sustaining devices licensed under the label and device package or
PHS Act. proposed requirements for
submission of data to the
GUDID.
[[Page 69395]]
Implantable devices would have
to bear a UDI as a permanent
marking on the device itself 1
year earlier than first
proposed.
Class II implantable, life-supporting, Would have to bear a UDI on the
and life-sustaining devices. label and device package and
submit data to the GUDID 1
year earlier than first
proposed.
Implantable devices would have
to bear a UDI as a permanent
marking on the device itself 3
years earlier than first
proposed.
Class I implantable, life-supporting, Would have to bear a UDI on the
and life-sustaining devices, and label and device package and
implantable, life-supporting, and life- submit data to the GUDID 3
sustaining devices that have not been years earlier than first
classified into class I, II, or III. proposed.
Implantable devices would have
to bear a UDI as a permanent
marking on the device itself 5
years earlier than first
proposed.
------------------------------------------------------------------------
D. Request for Comments
This amendment announces changes to the proposed rule required by
FDASIA. The comment period on the proposed rule closed on November 7,
2012. We request comments only on the changes discussed in this
amendment to the proposed rule and may decline to consider other
comments submitted to this docket.
III. Legal Authority for the Proposed Rule
Section 226 of the Food and Drug Administration Amendments Act
(Pub. L. 110-85) (2007), amended the FD&C Act by adding a new section
519(f). This section provides for FDA to issue regulations establishing
a unique device identification system for medical devices. In addition,
section 510(e) of the FD&C Act (21 U.S.C. 360(e)) authorizes FDA to
issue regulations to ``prescribe a uniform system for identification of
devices'' and to require persons to ``list such devices in accordance
with such system.'' Therefore, FDA is issuing the provisions of this
proposed rule that would establish a unique device identification
system under sections 510(e), 519(f), and 701(a) (21 U.S.C. 371(a)) of
the FD&C Act (which provides FDA the authority to issue regulations for
the efficient enforcement of the FD&C Act).
Devices for which there has been a failure or refusal to furnish
any material or information required by or under section 519 of the
FD&C Act respecting the device are misbranded under section 502(t)(2)
of the FD&C Act (21 U.S.C. 352(t)(2)). The failure or refusal to
furnish any material or information required by or under section 519 of
the FD&C Act is a prohibited act under section 301(q)(1)(B) of the FD&C
Act (21 U.S.C. 331(q)(1)(B)).
Section 701(a) of the FD&C Act gives FDA the authority to issue
regulations for the efficient enforcement of the FD&C Act. By requiring
a UDI to appear on the label of devices, and by establishing the GUDID,
the proposed rule is designed to improve the accuracy and precision of
adverse event reporting, as required by section 519(a) and (b) of the
FD&C Act, which will enable FDA to more quickly and precisely identify
device problems, such as safety and/or effectiveness concerns. Once a
problem is identified, whether through improved reporting or otherwise,
the presence of the UDI on the device label, packaging, in certain
cases directly marked on the device itself, and in the GUDID will
enable FDA to more efficiently and effectively respond, and protect the
public health by addressing the problem using one or more of the
regulatory tools that Congress has provided for this purpose, such as
notification or mandatory recall under section 518 of the FD&C Act (21
U.S.C. 360h), tracking under section 519(e) of the FD&C Act, ensuring
the adequacy of a voluntary recall with the assistance of reports of
corrections and removals as required by section 519(g) of the FD&C Act,
or seizing a device that is adulterated under section 501 of the FD&C
Act (21 U.S.C. 351) and/or misbranded under section 502 of the FD&C
Act. Thus, these provisions of the proposed rule are issued under the
authority of these sections in addition to the broad authority of
section 519(f) of the FD&C Act.
Section 510(j) of the FD&C Act requires listing information to be
accompanied by, at minimum, the label, package insert, and a
representative sampling of any other labeling for the device (see
section 510(j)(1)(B)(ii)). For certain categories of devices, all
labeling must be submitted (see section 510(j)(1)(A) and (j)(1)(B)(i)
of the FD&C Act). We expect most of the information that would be
required to be submitted to the GUDID (see proposed Sec. 830.310), is
information that appears on the device label or in the package insert,
and is included in the information that is required to be submitted to
FDA by section 510(j) of the FD&C Act.
The provisions of the proposed rule that would require UDIs to be
included in various records and reports, allow the use of UDIs to
identify devices subject to reports of corrections and removals and
records of corrections of removals that are not required to be reported
to FDA, and require reporting of UDIs in periodic reports for class III
devices, are issued under the authority of sections 519 and 701(a) of
the FD&C Act.
The provisions of the proposed rule that would amend the Quality
System Regulation by requiring examination of the accuracy of the UDI
as part of the scope of the labeling inspection, that the device
history record include any UDI or universal product code (UPC), that
complaint records include any UDI or UPC, and that the service report
include an UDI or UPC, are issued under sections 520(f) (21 U.S.C.
360j(f)) and 701(a) of the FD&C Act.
The provisions of the proposed rule that would require the
inclusion of UDIs on reports regarding tracked devices is authorized by
sections 519(e) and 701(a) of the FD&C Act.
The provision of the proposed rule that would require that
postmarket surveillance plans submitted to FDA include the device
identifier of the devices involved is issued under sections 522 (21
U.S.C. 360l), and 701(a) of the FD&C Act.
Finally, the changes in proposed effective dates for devices that
are implantable, life-saving, and life sustaining, are pursuant to the
changes to section 519(f) of the FD&C Act made by section 614 of
FDASIA.
IV. Analysis of Impacts
Our July 10, 2012, document summarizes the analysis of impacts of
the proposed rule. The full analysis of impacts and findings that are
presented in Preliminary Regulatory Impact Analysis (RIA) of the
proposed rule remain unchanged (Ref. 10 of the July 10, 2012, proposed
rule). However, we are amending our summary of costs to include the
FDASIA requirement to
[[Page 69396]]
incorporate the revised implementation date of 2 years for devices that
are implantable, life-supporting, and life-sustaining. The July 10,
2012, RIA and the Addendum to the RIA (new Ref. 13) are available at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.
We lack sufficient information to estimate the number of
establishments that label life-supporting and life-sustaining devices
and would be affected by the FDASIA requirement. Therefore, for this
amended cost summary, we make a simplifying assumption that labelers of
all class II devices would comply with the UDI requirements in year 2
instead of year 3 as initially specified under the proposed rule.
Because the modified timeframe would advance the implementation date to
directly mark implantable, life-supporting, and life-sustaining
devices, we assume that labelers of class III devices that are implants
would comply with the direct marking requirements in year 2 instead of
year 3 as initially specified under the proposed rule. The effect of
these simplifying assumptions might be to overstate the annualized
costs for some labelers of class II devices that are not considered
life-supporting or life-sustaining devices, and to underestimate the
annualized costs for some labelers of class I devices that are
considered life-supporting or life-sustaining devices.
The amended summary of the total costs of the proposed rule for all
sectors is presented in the updated table 3 of this document. The total
present value of domestic costs for all affected sectors would be about
$554.8 million over 10 years with a 7 percent discount rate and $625.4
million at 3 percent. The total annualized costs over 10 years would be
$73.8 million at 7 percent and $71.1 million at 3 percent. The total
increase in annualized costs to domestic labelers compared to the
proposed rule is about $5.4 million at 7 percent over 10 years.
Updated Table 3--Summary of the Estimated Regulatory Costs of the Proposed Rule
[2010 dollars] 1 2
----------------------------------------------------------------------------------------------------------------
Total present value of cost over 10 Total annualized costs over 10 years
years ($ million) ($ million)
Affected sectors ------------------------------------------------------------------------------
3 Percent 7 Percent 3 Percent 7 Percent
----------------------------------------------------------------------------------------------------------------
Domestic Labelers................ $608.3............ $540.2............ $69.2............. $71.9.
Issuing Agencies................. $1.0.............. $0.9.............. $0.1.............. $0.1.
FDA.............................. $16.1............. $13.7............. $1.8.............. $1.8.
Imports.......................... Not quantified.... Not quantified.... Not quantified.... Not quantified.
------------------------------------------------------------------------------
Total Domestic Cost of the $625.4............ $554.8............ $71.1............. $73.8.
Proposed Rule.
----------------------------------------------------------------------------------------------------------------
\1\ Present value and annualized costs calculated at the beginning of the period.
\2\ Domestic costs for labelers are revised to reflect FDASIA requirement that labelers of affected devices
comply in year 2. However, FDA's revised estimate assumes that all class II devices would comply in year 2.
Updated table 1 (and identical updated table 4 of the proposed
rule) presents the Regulatory Information Service Center (RISC) and
Office of Information and Regulatory Affairs (OIRA) Combined
Information System (ROCIS) accounting information under the assumption
that labelers of all class II devices would comply with the UDI
requirements in year 2 and that all labelers of class II implantable
devices would comply with the direct marking requirements in year 2.
[[Page 69397]]
[GRAPHIC] [TIFF OMITTED] TP19NO12.001
V. Information Collection Requirements
The updates made by this proposed rule do not affect the estimate
we previously provided regarding our July 10, 2012, proposed rule.
In accordance with section 3507(d) of the PRA (44 U.S.C. 3501 et
seq.), the information collection or recordkeeping requirements
included in this proposed rule have been submitted for approval to OMB.
A copy of the supporting statement for this information collection is
available on the Internet at https://www.reginfo.gov/public/do/PRAMain
(OMB Number 0910-0720) and is posted to the docket at https://www.regulations.gov, in docket FDA-2011-N-0090 (Ref. 11 of the proposed
rule).
VI. Environmental Impact
FDA has 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.
VII. Updated Proposed Effective Dates
FDA updates Table 7--Effective Dates of UDI Regulatory
Requirements, in our July 10, 2012, proposed rule as follows.
[[Page 69398]]
Updated Table 7--Effective Dates of UDI Regulatory Requirements
----------------------------------------------------------------------------------------------------------------
Effective date Requirement
----------------------------------------------------------------------------------------------------------------
Immediately upon publication of a final rule... Requests for an exception or alternative to UDI labeling
requirements may be submitted pursuant to Sec. 801.35.
Sec. Sec. 830.100-830.130 (subpart C of part 830, concerning
accreditation of issuing Agencies) and Sec. 830.10
(incorporation by reference of certain standards) go into
effect. This will allow applications for accreditation as an
issuing Agency to be submitted to FDA immediately.
One year after publication of a final rule..... Dates on medical device labels must be formatted as required by
Sec. 801.18.
The label and package of class III medical devices and devices
licensed under the PHS Act must bear a UDI. Sec.
801.20(b)(1).
Data for class III devices and devices licensed under the PHS
Act that are required to be labeled with a UDI must be
submitted to the GUDID data base. Sec. 830.300.
Two years after publication of a final rule.... The label and package of implantable, life-supporting, and life-
sustaining devices that are not class III devices or licensed
under the PHS Act must bear a UDI. Sec. 801.20(b)(2).
Data for implantable, life-supporting, and life-sustaining
devices that are not class III devices or licensed under the
PHS Act and that are required to be labeled with a UDI, must
be submitted to the GUDID data base. Sec. 830.300.
All implantable devices required to be labeled with a UDI must
bear a UDI as a permanent marking on the device itself. Sec.
801.50.
Three years after publication of a final rule.. Class III devices required to be labeled with a UDI must bear a
UDI as a permanent marking on the device itself if the device
is (1) a device intended to be used more than once and
intended to be sterilized before each use, or (2) stand-alone
software regulated as a medical device. Sec. 801.50.
The label and package of class II medical devices must bear a
UDI. Sec. 801.20(b)(3).
Data for class II devices that are required to be labeled with
a UDI, must be submitted to the GUDID data base. Sec.
830.300.
Five years after publication of a final rule... Class II devices required to be labeled with a UDI must bear a
UDI as a permanent marking on the device itself if the device
is (1) a device intended to be used more than once and
intended to be sterilized before each use, or (2) stand-alone
software regulated as a medical device. Sec. 801.50.
The label and package of class I medical devices and devices
that have not been classified into class I, class II, or class
III must bear a UDI. Sec. 801.20(b)(4), (5).
Data for class I devices and devices that have not been
classified into class I, class II, or class III that are
required to be labeled with a UDI must be submitted to the
GUDID data base. Sec. 830.300.
Seven years after publication of a final rule.. Class I devices and devices that have not been classified into
class I, class II, or class III required to be labeled with a
UDI must a bear UDI as a permanent marking on the device
itself if the device is (1) a device intended to be used more
than once and intended to be sterilized before each use, or
(2) stand-alone software regulated as a medical device. Sec.
801.50.
90 days after publication of a final rule...... All other provisions go into effect, although some will have no
practical effect until other provisions listed in this table
go into effect.
----------------------------------------------------------------------------------------------------------------
VIII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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, the Agency tentatively concludes that the proposed 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.
IX. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
X. References
We have not removed any references listed in the July 10, 2012,
proposed rule. We are adding new references 12 and 13 to account for
the additional costs attributable to the FDASIA amendment of section
519(f) of the FD&C Act, specifically the requirement that FDA must
implement the regulation with respect to devices that are implantable,
life-supporting, and life-sustaining not later than 2 years after we
publish a final rule.
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
12. List of medical devices, by product code, that FDA considers to
be implantable, life-saving, and life-sustaining for purposes of
section 614 of FDASIA, amending section 519(f) of the FD&C Act,
November 2012.
13. Addendum to the Preliminary Regulatory Impact Analysis of the
Proposed Rule to Require a Unique Device Identification System, Docket
No. FDA-2011-N-0090.
List of Subjects in 21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 801, as
proposed to be amended in the Federal Register of July 10, 2012 (77 FR
40736), be further amended as follows:
PART 801--LABELING
1. The authority citation for part 801 continues to read as
follows:
[[Page 69399]]
Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
Subpart B--[Amended]
2. Revise Sec. 801.20(b) to read as follows:
Sec. 801.20 Label to bear a unique device identifier (UDI).
* * * * *
(b) Effective dates. The requirements of paragraph (a) of this
section become effective:
(1) If the device is a class III medical device or is a device
licensed under section 351 of the Public Health Service Act, as
amended, 5 U.S.C. 262, [A DATE WILL BE ADDED THAT IS 1 YEAR AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(2) If the device is an implantable, life-supporting, or life-
sustaining device, and is not a class III device or a device licensed
under section 351 of the Public Health Service Act, as amended, 5
U.S.C. 262, [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(3) If the device is a class II medical device not covered by
paragraph (2), [A DATE WILL BE ADDED THAT IS 3 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(4) If the device is a class I medical device not covered by
paragraph (2), [A DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(5) If the device is not classified into class I, II, or III, [A
DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register].
* * * * *
3. Revise Sec. 801.50(d) to read as follows:
Sec. 801.50 Devices that must be directly marked with a unique device
identifier.
* * * * *
(d) Effective dates. The requirements of this section apply to a
device that is an implantable, life-supporting, or life-sustaining
device [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE Federal Register], and to any other device 2
years after the date that applies to the device under Sec. 801.20(b).
* * * * *
Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28015 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P
