Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, 64443-64458 [2018-27015]

Agencies

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

[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Rules and Regulations]
[Pages 64443-64458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 860

[Docket No. FDA[hyphen]2013-N-1529]
RIN 0910-AH75


Medical Device Classification Procedures: Incorporating Food and 
Drug Administration Safety and Innovation Act Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule to amend its regulations governing classification 
and reclassification of medical devices to conform to the applicable 
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as 
amended by the Food and Drug Administration Safety and Innovation Act 
(FDASIA). FDA is also making additional changes unrelated to the FDASIA 
requirements, to update its regulations governing the classification 
and reclassification of medical devices. FDA is taking this action to 
codify the procedures and criteria that apply to the classification and 
reclassification of medical devices and to provide for classification 
of devices in the lowest regulatory class consistent with the public 
health and the statutory scheme for device regulation.

DATES: This rule is effective March 18, 2019.

ADDRESSES: 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 final rule into 
the ``Search'' box and follow the prompts, and/or go to Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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): Ana Loloei, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave, Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002.
    For information concerning the final rule as it relates to devices 
regulated by the Center for Biologics Evaluation and Research (CBER): 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire

[[Page 64444]]

Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Terms, Abbreviations, and Commonly Used Acronyms in 
This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments in Response to the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Comments and FDA Response on the Proposed Definitions
    D. Comments and FDA Response on FDASIA Implementation
    E. Comments and FDA Response on Removal of Petition 
Requirements: Classification Questionnaire and Supplemental Data 
Sheet
    F. Comments on Other Proposed Conforming Changes and Technical 
Amendments to the Part 860 Regulations
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Consultation and Coordination with Indian Tribal Governments
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to amend part 860 of title 21 of the 
Code of Federal Regulations (CFR) (part 860), to conform the applicable 
provisions governing the classification and reclassification of medical 
devices to the FD&C Act as amended by FDASIA (Pub. L. 112-144). FDASIA, 
which became effective on July 9, 2012, established new processes for 
requiring premarket approval (PMA) applications for preamendments 
devices and for the reclassification of devices by administrative 
order, instead of by rulemaking. In this final rule, FDA also is 
amending the provisions of its regulations governing reclassifications 
initiated by FDA to incorporate the process for issuing administrative 
orders and to update generally the part 860 regulations governing the 
classification and reclassification of devices to conform them to the 
FDASIA changes and current FDA practices. This final rule provides for 
the classification of devices in the lowest regulatory class consistent 
with the public health and the statutory scheme for device regulation. 
We are changing the title of this rulemaking from ``Medical Device 
Classification Procedures'' to ``Medical Device Classification 
Procedures: Incorporating Food and Drug Administration Safety and 
Innovation Act Procedures'' to reflect the limited purpose of this 
final rule.

B. Summary of the Major Provisions of the Final Rule

    FDASIA amended the FD&C Act provisions for reclassification of 
devices and for requiring PMA applications for preamendments class III 
devices to change from a rulemaking proceeding to an administrative 
order process. Under the FD&C Act as amended by FDASIA, prior to 
publication of a final order reclassifying a device or requiring a PMA 
application for a preamendments class III device, FDA must publish a 
proposed order in the Federal Register, consider any comments submitted 
on the proposed order, and hold a device classification panel meeting 
(see sections 513(e) and 515(b) of the FD&C Act (21 U.S.C. 360c(e) and 
360e(b))). To reflect these procedural changes, FDA is issuing this 
final rule to amend our regulations (amended Sec. Sec.  860.130, 
860.132 and 860.133 of this final rule).
    This final rule also clarifies the process where reclassification 
of a postamendments device or a transitional device is initiated by 
FDA, rather than in response to a petition (see sections 513(f)(3) and 
520(l) of the FD&C Act (21 U.S.C. 360c(f)(3) and 360j(l))). 
Specifically, this rule details the procedures for these 
reclassification actions, which consist of a proposed reclassification 
order, optional panel consultation, and a final reclassification order 
published in the Federal Register following consideration of comments 
and any panel recommendations or comments (amended Sec. Sec.  
860.134(c) and 860.136(c) of this final rule). This final rule also 
removes the requirement for a hearing under part 16 (21 CFR part 16) 
for reclassifying transitional devices, because we believe the process 
in this final rule providing for a proposed order, panel consultation 
as appropriate, consideration of comments, and final order provides 
sufficient opportunity for participation and review of reclassification 
of transitional devices.
    This final rule also removes two definitions specifically 
pertaining to FDA forms that the Agency is eliminating under this rule, 
as we no longer find the forms useful. This rule does not finalize any 
of the other proposed changes to the current part 860 definitions.

C. Legal Authority

    Section 608 of FDASIA amended the procedures for reclassification 
of devices and for requiring PMA applications for preamendments class 
III devices (sections 513(e) and 515(b) of the FD&C Act, respectively). 
FDASIA amended both provisions to remove the prior requirement for a 
rulemaking proceeding and to replace it with an administrative order 
process, instead of rulemaking under section 553 of the Administrative 
Procedure Act (APA) (5 U.S.C. 553). Section 701(a) of the FD&C Act (21 
U.S.C. 371(a)) permits the issuance of regulations for the efficient 
enforcement of the FD&C Act.

D. Costs and Benefits

    This final rule amends the regulations governing the process for 
classification and reclassification of medical devices. It codifies 
FDASIA amendments to the FD&C Act that are already in effect and 
updates generally the regulations for device classification and 
reclassification proceedings to provide clarity.
    The costs of this final rule include initial learning costs faced 
by medical device manufacturers and affiliated regulatory consultants 
upon publication of the rule, in addition to annual costs incurred by 
the Agency and industry related to preparation and participation in 
additional panel meetings. We estimate the rule's present discounted 
cost, over a 10-year period, to equal $2 million at a 3 percent 
discount rate and $1.7 million at a 7 percent discount rate. Our 
estimates of the annualized costs are $0.24 million at a 3 percent 
discount rate and $0.24 million at a 7 percent discount rate.
    The principal benefits of this final rule stem from the reduction 
in regulatory and economic burden that will accompany the elimination 
of some paperwork filing requirements, in addition to the enhanced 
consistency and uniformity across reclassification proceedings. These 
cost savings will accrue to both medical device manufacturers and to 
the Agency. Further benefits may be derived from the decreased time a 
petition will need to be reviewed for device reclassification and the 
subsequent potential benefits realized by consumers and producers. We 
estimate the overall cost savings over the next 10 years to be $0.05 
million at a 3 percent discount rate and $0.04 million at a 7 percent 
discount rate. Our estimates of the annualized cost savings are $0.006 
million at a 3 percent discount rate and $0.006 million at a 7 percent 
discount

[[Page 64445]]

rate. The estimated costs and cost savings are summarized for a 10-year 
period in table 1 and for an infinite period in table 2. Additional 
qualitative analysis of this final rule's benefits is included in the 
Final Regulatory Impact Analysis.

                                                  Table 1--Summary of Estimated Costs and Cost Savings
                                    [In $ Millions 2016 dollars, at 3% and 7% discount rates, over a 10-year period]
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                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (3%)        (3%)            (3%)        Primary (7%)        (7%)            (7%)
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Present Value of Costs..................................          $2.002          $0.014         $23.050          $1.668          $0.014         $18.982
Present Value of Cost Savings...........................           0.047           0.041           0.061           0.039           0.034           0.050
Present Value of Net Costs..............................           1.975         (0.027)          22.989           1.629         (0.020)          18.932
Annualized Costs........................................           0.237           0.002           2.702           0.237           0.002           2.703
Annualized Cost Savings.................................           0.006           0.005           0.007           0.006           0.005           0.007
Annualized Net Costs....................................           0.231         (0.003)           2.695           0.231         (0.003)           2.696
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Notes: Benefits include reduction in administrative burden and enhanced clarity and uniformity in petition process. Range of estimates captures
  uncertainty around petitioner response.


                                        Table 2--E.O. 13771 Summary Table
               [In $ Millions 2016 dollars, at a 7% discount rate, over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
                                                                                    Lower bound     Upper bound
                                                                   Primary (7%)        (7%)            (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..........................................          $3.377          $0.014         $38.593
Present Value of Cost Savings...................................           0.080           0.070           0.102
Present Value of Net Costs......................................           3.297         (0.056)          38.491
Annualized Costs................................................           0.236           0.001           2.700
Annualized Cost Savings.........................................           0.006           0.005           0.007
Annualized Net Costs............................................           0.230         (0.005)           2.693
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II. Table of Terms, Abbreviations, and Commonly Used Acronyms in This 
Document

    Table 3--List of Terms, Abbreviations, and Commonly Used Acronyms
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    Term, abbreviation, or
           acronym                           What it means
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1976 Amendments..............  Medical Device Amendments of 1976 (Pub.
                                L. 94-295).
510(k).......................  Premarket notification.
Agency.......................  Food and Drug Administration.
APA..........................  Administrative Procedure Act, 5 U.S.C.
                                550 et seq.
CFR..........................  Code of Federal Regulations.
De Novo request..............  Pertaining to the classification process
                                under section 513(f)(2) of the FD&C Act
                                (21 U.S.C. 360c(f)(2)).
E.O..........................  Executive Order.
FACA.........................  Federal Advisory Committee Act, 5 U.S.C.
                                App.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act, 21
                                U.S.C. 301 et seq.
FDA..........................  Food and Drug Administration.
FDASIA.......................  Food and Drug Administration Safety and
                                Innovation Act.
FDASIA amendments............  Section 608 of FDASIA.
PMA..........................  Premarket approval.
Preamendments device.........  Medical device that was in commercial
                                distribution before the May 28, 1976
                                enactment of the 1976 Amendments.
Part 860.....................  21 CFR part 860.
Postamendments device........  Medical device that was not in commercial
                                distribution before the May 28, 1976,
                                enactment of the 1976 Amendments.
PRA..........................  Paperwork Reduction Act of 1995, 44
                                U.S.C. 3501-3520.
Transitional device..........  Medical device that was regulated as a
                                new drug before the May 28, 1976,
                                enactment of the 1976 Amendments.
UDI..........................  Unique Device Identifier.
U.S.C........................  United States Code.
We or us.....................  Food and Drug Administration.
------------------------------------------------------------------------


[[Page 64446]]

III. Background

A. Need for the Regulation/History of This Rulemaking

    The Medical Device Amendments of 1976 (Pub. L. 94-295) (the ``1976 
Amendments'') amended the FD&C Act and established a comprehensive 
system for the regulation of medical devices intended for human use. 
The FD&C Act establishes the following three categories (classes) of 
devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness: class I 
(general controls), class II (special controls), and class III 
(premarket approval) (section 513(a)(1) of the FD&C Act).
    To change a device classification, FDA can initiate a 
reclassification or an interested person can petition FDA to reclassify 
a device based on new information (section 513(e) of the FD&C Act). 
Prior to FDASIA, FDA was required to use a rulemaking proceeding to 
reclassify devices based on new information, in accordance with the 
rulemaking provisions of the APA (see 5 U.S.C. 553). FDASIA amended the 
FD&C Act to remove the rulemaking requirement and instead to authorize 
reclassification through an administrative order process (section 608 
of FDASIA, amending section 513(e) of the FD&C Act). The FD&C Act, as 
amended by FDASIA, requires that FDA, prior to publishing a final 
order, must publish a proposed order in the Federal Register and 
consider any comments submitted on the proposed order. FDASIA also 
amended the FD&C Act to require that FDA must hold a device 
classification panel meeting on the proposed reclassification (section 
513(e) of the FD&C Act). This final rule implements these statutory 
changes (section 513(e) of the FD&C Act; amended Sec.  860.130 of this 
final rule).
    FDASIA also amended the provisions of the FD&C Act authorizing FDA 
to require submission of a PMA application for a preamendments class 
III device (referred to as a ``call for PMAs''). Preamendments devices 
are devices that were in commercial distribution before the enactment 
of the 1976 Amendments. Under the FD&C Act, preamendments devices 
classified into class III may be marketed upon clearance of a 510(k) 
submission, and submission of a PMA is not required until FDA has 
issued a final order requiring premarket approval (section 515(b) of 
the FD&C Act). As amended by FDASIA, the FD&C Act requires that FDA, in 
its call for PMAs, publish a proposed order in the Federal Register, 
hold a classification panel meeting, and consider comments on the 
proposed order (section 515(b) of the FD&C Act, as amended by FDASIA).
    Under the FD&C Act, FDA's call for PMAs must, among other things, 
contain an opportunity for interested persons to request a change in 
the classification of the device based on new information (section 
515(b)(2) of the FD&C Act). After consideration of comments on the 
proposed order and findings, FDA must either: (1) Finalize the call for 
PMAs by issuing an administrative order requiring approval of a PMA and 
publishing in the Federal Register findings with respect to: (i) The 
degree of risk of illness or injury designed to be eliminated or 
reduced by requiring the device to have an approved PMA or a declared 
completed product development protocol and (ii) the benefit to the 
public from the use of the device; or (2) publish a notice in the 
Federal Register terminating the proceeding and initiate a 
reclassification proceeding based on new information (section 515(b)(3) 
of the FD&C Act, as amended by FDASIA; see section 513(e) of the FD&C 
Act).
    FDASIA amended the FD&C Act to require the use of administrative 
orders, rather than rulemaking, when FDA calls for PMAs for a 
preamendments device remaining in class III (section 515(b) of the FD&C 
Act, as amended by FDASIA), and this final rule implements these 
statutory changes (new Sec.  860.133 of this final rule).
    FDA refers to a device that was not in commercial distribution 
before the 1976 Amendments as a postamendments device. Postamendments 
devices are classified automatically into class III by statute, without 
any rulemaking process (section 513(f)(1) of the FD&C Act). A 
postamendments device remains in class III and is subject to the PMA 
requirements unless and until: (1) FDA reclassifies the device into 
class I or II; (2) FDA issues an order classifying the device into 
class I or II via the De Novo classification process (see section 
513(f)(2) of the FD&C Act); or (3) FDA issues an order finding the 
device to be substantially equivalent to a predicate device that does 
not require the filing of a PMA (see section 513(i) of the FD&C Act).
    FDA may initiate, or the manufacturer or importer of a device may 
petition for, the reclassification of a postamendments device 
classified into class III by operation of law (section 513(f)(3) of the 
FD&C Act). This final rule clarifies the process where reclassification 
of a postamendments device remaining in class III is initiated by FDA 
rather than by a petitioner. This FDA-initiated reclassification 
process, as detailed in this final rule, consists of a proposed 
reclassification order, optional panel consultation, and a final 
reclassification order published in the Federal Register following 
consideration of comments and any panel recommendations or comments 
(new Sec.  860.134(c) of this final rule). The reclassification order 
may, as appropriate, establish special controls to provide reasonable 
assurance of the safety and effectiveness of the device (new Sec.  
860.134(d) of this final rule).
    Under the 1976 Amendments, Congress classified all those devices 
previously regulated as new drugs into class III (generally referred to 
as transitional devices). Under the FD&C Act, FDA may initiate, or the 
manufacturer or importer of a device may petition for, the 
reclassification of a transitional device remaining in class III 
(section 520(l)(2) of the FD&C Act). This final rule details the 
process for reclassification of transitional devices initiated by FDA 
(new Sec.  860.136(c) of this final rule). This process consists of a 
proposed reclassification order, optional panel consultation, and a 
final reclassification order published in the Federal Register 
following consideration of comments and any panel recommendations or 
comments. This final rule also removes the requirement for a part 16 
hearing for transitional devices because we believe the process 
providing for a proposed order, panel consultation as appropriate, 
consideration of comments, and final order provide sufficient 
opportunity for participation and review of reclassification of 
transitional devices.
    In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued 
a proposed rule entitled ``Medical Device Classification Procedures'' 
and requested public comment on the proposed rule within 90 days 
following its publication.
    One of the comments requested that the comment period be extended 
for an additional 90 days due to the complexity and importance of the 
issues raised in the proposed rule. In the Federal Register of June 12, 
2014 (79 FR 33711), FDA reopened the comment period for an additional 
90 days.
    By direct final rule published on December 24, 2014 (79 FR 77387) 
and on August 21, 2017 (82 FR 39534), FDA made technical amendments to 
its existing part 860 regulations to update the mailing address for 
reclassification petitions currently found at Sec.  860.123(b)(1); 
neither the proposed rule nor this final rule changes the updated and 
amended mailing address.
    FDA believes this rule will assist the Agency with efficient 
enforcement of the FD&C Act because it provides

[[Page 64447]]

increased clarity, uniformity, and predictability for stakeholders, 
particularly regulated entities, regarding the procedural framework for 
reclassifying medical devices and calling for PMAs.

B. Summary of Comments in Response to the Proposed Rule

    The comments on the proposed rule break down into two groups: 
Generally favorable and supportive comments on the proposals to 
implement the FDASIA-mandated administrative order procedures to change 
a device classification or when FDA calls for PMAs; but unfavorable 
comments on the proposed amendment of the definitions in part 860. Many 
of the commenters expressed concern that the proposed updates and 
clarifications to the definitions would result in more devices being 
classified into burdensome, higher-class device categories, 
particularly into class III. Other commenters opposed these changes 
because they were perceived as making the class definitions, 
particularly for class III, too specific and therefore narrower, which 
might result in unwarranted reclassification of high-risk devices into 
lower classes. Regardless of the comment's perspective on the effect of 
the definitions, the comments questioned our legal authority to make 
the changes. Other comments expressed uncertainty about our intent in 
proposing to change the definitions currently in part 860 and 
recommended that we confirm in the final rule that the purpose of this 
rulemaking is only to codify existing FDA practices and not to make 
substantive changes, except as required by the FDASIA amendments.

IV. Legal Authority

    Among the provisions that provide authority for this final rule are 
sections 201(h), 501(f), 510(k), 513(d), (e), (f), and (i), 515(b) and 
(f), 520(l), and 701(a) of the FD&C Act (21 U.S.C. 321(h), 351(f), 
360(k), 360c(d), (e), (f), and (i), 360e(b) and (f), 360j(l), and 
371(a)).
    As amended by section 608 of FDASIA, sections 513(e) and 515(b) of 
the FD&C Act mandate that the reclassification of medical devices and 
the call for PMAs must be done by administrative order, instead of by 
rulemaking. This final rule finalizes the conforming edits to 
applicable regulations in part 860 to be consistent with the 
administrative order procedures mandated by section 608 of FDASIA. 
Section 701(a) of the FD&C Act permits the issuance of regulations for 
the efficient enforcement of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received 15 sets of comments on the proposed rule, mostly from 
manufacturers of medical devices and their trade representatives and 
associations. Comments were also received from medical and health care 
professionals, patient advocacy groups, and consumers.
    We describe and respond to the comments in sections B through F of 
this section. We have numbered each comment to help distinguish between 
different comments. We have grouped similar comments together under the 
same number, and, in some cases, we have separated different issues 
discussed in the same set of comments and designated them as distinct 
comments for purposes of our responses. The number assigned to each 
comment or comment topic is purely for organizational purposes and does 
not signify the comment's value or importance or the order in which 
comments were received.

B. Description of General Comments and FDA Response

    Some comments made general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. In 
the following paragraphs, we discuss and respond to such general 
comments.
    (Comment 1) Several comments opposed finalizing the proposed rule, 
and recommended that the Agency should either withdraw the proposed 
rule and re-propose a rule with only the provisions required to 
implement section 608 of FDASIA, or issue a revised proposed rule to 
implement only the FDASIA-mandated changes to the part 860 regulations 
pertaining to reclassifications and start a separate rulemaking to 
update and clarify the other provisions of part 860. One of the 
comments recommended, alternatively, that the Agency should implement 
the FDASIA-required changes to the part 860 regulations governing 
device reclassification procedures and should make explicitly clear 
that, except to finalize edits to part 860 to conform to changes that 
FDASIA made to the FD&C Act, the changes in this rule are meant to 
update and clarify the part 860 regulations to reflect FDA's existing 
practices and should not be interpreted as substantive changes.
    (Response 1) As recommended in the last comment, FDA confirms that 
it is finalizing the proposed rule for the purpose of implementing 
FDASIA and updating and clarifying the part 860 regulations, without 
the intent otherwise to make substantive changes. Further, because this 
final rule does not finalize any of the proposed definitions in the 
proposed rule, as further discussed in our response to Comment 5, this 
rule is only finalizing the FDASIA-required changes and a few other 
edits, as proposed, to update and clarify part 860.
    (Comment 2) Two comments requested that FDA hold a public workshop 
to solicit stakeholder dialogue on changes that would be helpful or 
needed concerning the part 860 regulations.
    (Response 2) The principal purpose of this final rule is to 
implement the provisions of FDASIA mandating administrative order 
procedures for FDA actions reclassifying medical devices and calling 
for PMAs and to update and clarify the existing part 860 regulations, 
as needed, to, among other things, conform them to the FDASIA-mandated 
changes and current FDA terminology.
    We believe that the issues underlying this rulemaking are 
adequately developed in the proposed rule and that the comments 
received and FDA responses in this final rule robustly discuss these 
issues. As discussed in our response to Comment 5, this final rule does 
not finalize any of the proposed definitions in the proposed rule (see 
proposed Sec.  860.3). As such, we do not believe that a public 
workshop is needed to seek further input prior to finalizing this 
rulemaking. Apart from this rulemaking, we continue to welcome 
stakeholder communication about how FDA might improve the part 860 
regulations.
    (Comment 3) A commenter requested that FDA clarify the interplay 
between its regulations and the use of administrative orders in the 
device classification and reclassification process under this final 
rule, to establish procedures for updating the relevant CFR sections 
when FDA classifies a device by administrative order, and to clarify 
whether there will be a central site for viewing orders and supporting 
documentation.
    (Response 3) The FDASIA amendments and this final rule do not 
change the types of classification actions that the Agency is able to 
take under the FD&C Act and part 860 nor the way that notices of these 
actions are published when FDA classifies a device. As explained in 
Section III.A, Need for the Regulation/History of This Rulemaking, 
FDASIA revises the procedures that the Agency must use to reach its 
decision to reclassify or to call for PMAs, i.e., to an administrative

[[Page 64448]]

order process instead of rulemaking (see sections 513(e) and 515(b) of 
the FD&C Act, as amended by section 608 of FDASIA). For other types of 
reclassifications, the Agency has been issuing administrative orders 
published in the Federal Register (see sections 513(f)(3) and 520(l)(2) 
of the FD&C Act). Our use of administrative orders is governed by the 
relevant provisions of the FD&C Act and ultimately by the provisions 
finalized in this rule.
    The Agency will announce its reclassification orders by publication 
of the proposed and final orders in the Federal Register. This 
publication process for reclassification actions is the same as used 
before the enactment of FDASIA when reclassifications were accomplished 
by rulemaking, i.e., by notice of such action published in the Federal 
Register.
    The FDASIA amendments also require FDA to post annually the number 
and type of devices reclassified in the previous calendar year (section 
608(c) of FDASIA). Since the enactment of FDASIA, the Agency has been 
listing its reclassification orders, initiated by the Agency or in 
response to a petition, on two websites, found respectively at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm and at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm378724.htm. We intend to update these websites 
periodically and maintain them to assure transparency and public 
availability of this information.
    (Comment 4) Commenters expressly supported our goal to ensure 
classification of devices in the lowest regulatory class consistent 
with the protection of public health and the statutory scheme for the 
device.
    (Response 4) As reiterated in the Summary of this final rule, the 
Agency reaffirms that this is a goal of our device classification 
system and one of the purposes of this rulemaking.

C. Comments and FDA Response on the Proposed Definitions

    The proposed rule suggested revising the current part 860 
definitions of ``class I'', ``class II'', and ``class III'', in part by 
pulling out language now found in the definitions of ``class I'' and 
``class II'' into stand-alone definitions of the terms ``general 
controls'' and ``special controls.'' We also proposed to update and 
clarify our part 860 regulations by revising the current definitions of 
the terms ``generic type of device,'' ``implants,'' and ``supporting or 
sustaining human life'' and by defining the new term ``special controls 
guideline.'' Because the intent of the proposed modifications to the 
part 860 definitions was to provide clarity and not to implicitly 
change the classification/reclassification process, and because none of 
these definitional changes is needed to conform the part 860 
regulations to the administrative order procedures required by FDASIA, 
we are not finalizing the proposed definitions in this final rule.
    We grouped comments related to the proposed definitions together 
under the same number below and are responding to them collectively.
    (Comment 5) We received a significant number of comments on the 
proposed definitions of the proposed rule (see proposed Sec.  860.3). 
Several comments opposed finalizing these proposed definitions stating 
that they conflicted with the statutory definitions of class I, II, and 
III, and if finalized, would result in uncertainty and the 
inappropriate classification of many products, as well as additional 
costs and paperwork burdens that should be analyzed in this rulemaking.
    Specifically, many of these comments opposed the proposed changes 
to the part 860 definition of ``class III'' because of the perception 
that the changes, if finalized, would make the definition overly broad 
and result in more devices being classified into class III, while other 
comments viewed the more detailed criteria of the proposed class III 
definition as possibly limiting FDA's ability to rely on other 
standards for assessing risk. Several comments contended that the 
proposed change of the wording of the definitions of class I and class 
II, by substituting the wording ``intended for a use'' in place of 
``for a use,'' would introduce a subjective intent criterion for 
devices that otherwise might be classified or reclassified into class I 
and would require or result in the up-classification of some devices. 
While not specifically opposing the stand-alone definition of general 
controls as proposed, several comments raised an overall concern about 
changing the definitions of class I and class II in this rulemaking, on 
the grounds that the proposed change is not required to implement 
section 608 of FDASIA. In addition, a number of commenters indicated 
that the terms ``general controls'' and ``special controls'' are well 
understood, and that there are few, if any, public health issues 
relating to their use in the part 860 regulations, and that changing 
the definitions will likely create uncertainty without benefit and 
disturb decades of reliance on the current class I, II, and III 
definitions.
    On the other hand, other commenters indicated that the proposed 
definition of ``class II'' was too broad, and that it would capture 
devices that they thought should be regulated as class III.
    Some commenters also opposed the proposed amendments to the 
definition of ``generic type of device.'' One commenter opposed 
allowing more than one generic type of device in a classification 
regulation, stating that the term ``generic type of device'' is 
synonymous with the scope of each classification regulation. Another 
commenter opposed using product codes as part of the definition, 
stating that they serve a limited and internal FDA purpose and are 
unnecessary in this rulemaking to implement section 608 of FDASIA.
    Several comments also requested that FDA clarify how 
reclassification determinations under the revised part 860 regulations 
would apply to previously approved or cleared devices, including the 
economic and paperwork burdens of the reclassifications imposed by the 
proposed definitions changed in this rulemaking and in future 
reclassifications authorized under this final rule.
    (Response 5) This rule does not finalize any of the proposed 
definitions in proposed Sec.  860.3. We do not believe, given the 
volume and diversity of opposing comments, that finalizing these 
definitions would add clarity or transparency to stakeholders' 
understanding of the part 860 regulations. However, as described in 
section V.E, we are finalizing the proposed removal of two definitions 
(Sec.  860.3(f) and (g)) associated with two forms. FDA did not receive 
any specific comments about the removal of these definitions.
    The principal purpose of this final rule is to implement section 
608 of FDASIA, which mandated administrative order procedures for FDA's 
actions for reclassifying medical devices and calling for PMAs. Our 
intent in proposing the revised definitions, and in updating and 
clarifying the part 860 regulations in the proposed rule, was to 
reflect our current regulatory practices and not to make substantive 
changes, except as needed to conform the current part 860 regulations 
to the FDASIA-mandated changes. Nonetheless, as stated above, we do not 
believe that it is necessary to finalize the proposed definitions. In 
this rulemaking, we are proceeding to finalize our other proposed 
updates and clarifications to part 860 to reflect our current 
regulatory practices and to

[[Page 64449]]

conform to the FDASIA-mandated changes.
    This rulemaking primarily amends the procedures for reclassifying 
devices and calling for PMAs. These procedural changes do not affect 
the classifications of previously cleared or approved devices. Further, 
as previously stated, we are not finalizing the proposed definitions; 
nor were the proposed definitions intended to reclassify any cleared or 
approved devices. Thus, further clarification of the status of 
previously cleared or approved devices, including an analysis of the 
economic or paperwork burden of such potential changes, is not 
necessary.

D. Comments and FDA Response on FDASIA Implementation

1. Administrative Order Procedures in Part 860 Proceedings
    This final rule implements the FDASIA amendments that change the 
following procedures to an administrative order process: (1) The 
process by which FDA calls for PMAs for preamendments devices and (2) 
the regulatory procedures for reclassifying medical devices based on 
new information in response to a petition, as well as for those begun 
at FDA's initiative (amended Sec. Sec.  860.84, 860.130, and 860.132 
and new Sec.  860.133 of this final rule, implementing sections 513(e) 
and 515(b) of the FD&C Act, as amended by section 608 of FDASIA). The 
administrative order process both for requiring PMA applications and 
for reclassification based on new information includes issuance of a 
final order in the Federal Register following publication of a proposed 
order in the Federal Register, a meeting of a device classification 
panel, and consideration of comments--notwithstanding 5 U.S.C. 553, 
which requires Agencies, including FDA, to follow the APA's procedures 
when engaging in rulemaking. We received no adverse comments concerning 
our proposed changes to amend the part 860 regulations for this 
purpose.
    This final rule also clarifies the process for when FDA initiates 
reclassification of devices under certain provisions of the FD&C Act 
that were not amended by FDASIA. The proposed rule suggested clarifying 
the procedures for FDA to take reclassification actions on its own 
initiative under these provisions, by clarifying the current 
administrative order process for reclassifying postamendments devices 
that have been automatically classified into class III (see section 
513(f)(3) of the FD&C Act; amended Sec.  860.134(c) and (d) of this 
final rule) and for reclassifying transitional devices, regulated as 
new drugs before 1976, that previously have been classified into class 
III (see section 520(l) of the FD&C Act; amended Sec.  860.136(c) and 
(d) of this final rule).
    This final rule clarifies, specifically, that FDA can reclassify 
any device from class III to either of the other two classes (amended 
Sec. Sec.  860.84(d)(6), 860.134(c), and 860.136(b)(4) and (c) of this 
final rule). This final rule also clarifies that reclassifications may 
be from any class to any other class, i.e., reclassification into a 
higher class (``up-classification'') or into a lower class (``down-
classification'') (amended Sec.  860.130(c)(1) through (3) of this 
final rule).
    (Comment 6) For postamendments devices eligible for the De Novo 
classification process under section 513(f)(2) of the FD&C Act, one 
commenter requested FDA to clarify how the De Novo process fits into 
the classification/reclassification process under part 860.
    (Response 6) This final rule does not affect the De Novo 
classification process. Any person who receives a not substantially 
equivalent determination in response to a 510(k) submission for a 
device that has not been previously classified under the FD&C Act may 
request FDA to classify the device (section 513(f)(2)(A)(i) of the FD&C 
Act). A person who determines that there is no legally marketed device 
upon which to base a determination of substantial equivalence may 
request FDA to classify the device without first submitting a 510(k) 
(section 513(f)(2)(A)(ii) of the FD&C Act). In either case, the 
classification criteria are the same (see section 513(a)(1) of the FD&C 
Act).
    When FDA classifies a device type as class I or II via the De Novo 
classification process, other manufacturers do not necessarily have to 
submit a De Novo request or PMA application in order to legally market 
a device of the same type. Instead, manufacturers can use the less 
burdensome pathway of 510(k) notification, when applicable, to legally 
market their device, because the device that was the subject of the 
original De Novo request can serve as a predicate device for a 
substantial equivalence determination. A device classified via the De 
Novo classification process may subsequently be reclassified under 
other provisions of the FD&C Act (see section 513(e) and (f)(3) of the 
FD&C Act).
    In the Federal Register of December 7, 2018 (83 FR 63127), FDA 
published a proposed rule to establish requirements for the De Novo 
classification process. The proposed rule, if finalized, implements the 
De Novo classification process under the FD&C Act and establishes 
procedures and criteria for the submission and withdrawal of a request 
for De Novo classification. The proposed requirements also establish 
procedures and criteria for FDA accepting, reviewing, granting, and 
declining a De Novo request.
    (Comment 7) Some comments questioned whether there is legal 
authority or rationale in a reclassification order under part 860 to 
down-classify an implant device or life-supporting or life-sustaining 
device into class I or class II.
    (Response 7) The FD&C Act directs FDA to classify and reclassify 
devices into one of three regulatory control categories based on the 
criteria set forth in the FD&C Act: Class I (general controls), class 
II (special controls), and class III (premarket approval), depending 
upon the degree of regulation necessary to provide reasonable assurance 
of their safety and effectiveness (section 513(a)(1) of the FD&C Act). 
There is no requirement in the statute that FDA classify all implant 
devices or life-supporting or life-sustaining devices (i.e., purported 
or represented for use in supporting or sustaining human life or use 
which is of substantial importance in preventing impairment of human 
health) into class III; nor is there a prohibition on classifying these 
devices into class I or class II.
    Class I devices are subject to a comprehensive set of regulatory 
authorities called general controls, which include provisions that 
relate to establishment registration and listing, premarket 
notification, prohibitions against adulteration and misbranding, 
records and reports, and good manufacturing practices (see section 
513(a)(1)(A) of the FD&C Act). General controls apply to all classes of 
medical devices and provide FDA with the means of regulating products 
to assure their safety and effectiveness.
    Class II devices are devices for which general controls, by 
themselves, are insufficient to provide reasonable assurance of the 
safety and effectiveness of the product, and for which there is 
sufficient information to establish special controls necessary to 
provide such assurance (see section 513(a)(1)(B) of the FD&C Act). For 
implant devices or life-supporting or life-sustaining devices to be 
classified or reclassified into class II, FDA additionally must 
describe the special controls that, in addition to general controls, 
are necessary to provide a reasonable assurance of safety and 
effectiveness of the device and how such controls

[[Page 64450]]

provide such assurance (section 513(a)(1)(B) of the FD&C Act).
    Class III devices are devices for which general controls, by 
themselves, are insufficient and for which there is insufficient 
information to establish special controls to provide reasonable 
assurance of the safety and effectiveness of the device, and are 
purported or represented to be for a use in supporting or sustaining 
human life or for a use which is of substantial importance in 
preventing impairment of human health, or present a potential 
unreasonable risk of illness or injury (see section 513(a)(1)(C) of the 
FD&C Act). Whether a device is life-supporting or life-sustaining is 
only one factor in determining whether the device should be classified 
as class III and is not determinative of a device's classification. FDA 
must also consider whether general controls by themselves are 
sufficient and whether there is sufficient information to establish 
special controls before classifying a device as class III.
    (Comment 8) One comment requested FDA define the term 
``unclassified'' or ``not classified'' devices and explain the 
classification and 510(k) process for devices that fall into these 
categories.
    (Response 8) FDA guidance provides explanations of the terms 
requested. ``Unclassified devices'' are preamendments devices for which 
a classification regulation has not been promulgated (Ref. 1). Until 
the unclassified device type is formally classified and a regulation 
established, marketing of new devices within this type will require 
submission of a 510(k). On the other hand, ``not classified devices'' 
are postamendments devices for which the Agency has not yet reviewed a 
marketing application or for which the Agency has not made a final 
decision on such a marketing application (Ref. 1). As we are not 
finalizing any of the proposed definitions in proposed Sec.  860.3 and 
there already are established definitions for ``unclassified'' and 
``not classified'' devices, it is not necessary, at this time, to add 
those definitions to part 860 in this rulemaking. Further, aside from 
conforming the regulatory procedures for certain reclassifications and 
calling for PMAs for class III preamendments devices to the FD&C Act as 
amended by FDASIA, this final rule does not affect FDA's traditional 
treatment of unclassified and not classified devices. Nor does this 
rule change the 510(k) process applicable to such devices. Future 
decisions that affect unclassified and not classified devices will be 
taken, as appropriate, on a case-by-case basis consistent with the 
relevant authority.
2. Classification Panels
    For reclassification proceedings based on new information and for 
proceedings calling for PMAs for a class III preamendments device, FDA 
must convene a classification panel and obtain panel recommendations on 
classification (sections 513(e) and 515(b) of the FD&C Act, as amended 
by FDASIA; amended Sec. Sec.  860.130(d)(1) and 860.133(b) of this 
final rule). On the other hand, for FDA-initiated reclassification 
proceedings for postamendments devices and transitional devices, which 
also involve administrative orders, FDA can, as in the past prior to 
the passage of FDASIA, choose whether to consult with a panel (sections 
513(f)(3) and 520(l) of the FD&C Act; amended Sec. Sec.  860.134(b) and 
(c)(2), 860.136(c)(2), and 860.125(a) of this final rule).
    The final rule includes minor changes to the current classification 
panel provisions of the part 860 regulations to update their 
terminology (see amended Sec. Sec.  860.84(d)(2) and 860.10(a) of this 
final rule, finalizing proposed Sec. Sec.  860.84(d)(2) and 860.93(a), 
respectively). The final rule also clarifies that, in the case of a 
recommended reclassification into class II, the panel must provide FDA 
its recommendation whether the device should be exempted from the 
premarket notification requirement under section 510(k) of the FD&C Act 
(amended Sec. Sec.  860.15(a) and 860.84(d)(4) of this final rule). The 
final rule also updates the docket information of the part 860 
regulations that indicates where panel recommendations are available 
for public viewing, by including the FDA website address (amended 
Sec. Sec.  860.84(e) and 860.134(b)(4) of this final rule). We received 
no comments on any of the changes referred to in this paragraph, and we 
are finalizing these changes as proposed.
    (Comment 9) One comment questioned why all reclassification 
petitions and proposed orders (including FDA-initiated orders) would 
not be referred to a classification panel and argued that section 608 
of FDASIA and logic dictate that all proposed reclassifications, 
regardless of who initiates the process, should be reviewed by a 
classification panel.
    (Response 9) FDA may refer a matter to a panel either because it is 
legally required to do so or because it chooses to do so at its own 
discretion. The FD&C Act, as amended by FDASIA, dictates specific 
circumstances in which FDA must hold a panel meeting prior to making a 
classification or reclassification decision, regardless of who 
initiates the process. For instance, the process for reclassifications 
based on new information requires that FDA issuance of an 
administrative order reclassifying a device be preceded by a proposed 
order, a meeting of a device classification panel, and consideration of 
comments to a public docket (section 513(e) of the FD&C Act, as amended 
by FDASIA). On the other hand, the FD&C Act permits FDA to determine 
whether to hold a panel meeting when FDA initiates the reclassification 
of a postamendments or a transitional device (sections 513(f)(3) and 
520(l) of the FD&C Act). In addition, when reclassifying a 
postamendments device in response to a petition, FDA ``may for good 
cause shown'' decide to consult with a panel (section 513(f)(3)(B) of 
the FD&C Act). FDASIA did not amend these authorities; and thus, a 
panel is not required for proceedings conducted under these authorities 
(amended Sec. Sec.  860.134 and 860.136 of this final rule).
    When acting at its own discretion, FDA generally considers taking a 
matter before a panel if, among other things, the matter is of 
significant public interest or there is additional or special expertise 
provided by the panel that could assist FDA in its decision making. 
Regardless of whether a panel meeting is held, the opportunity to 
submit comments to a public docket on the Agency's recommendation is an 
integral part of any such action. FDA also considers whether the 
process followed by FDA reflects the least burdensome approach to 
classification and reclassification of devices (section 
513(a)(3)(D)(ii) of the FD&C Act).
    (Comment 10) Several comments objected to FDA's interpretation of 
section 608 of FDASIA in the proposed rule that would allow panel 
meetings to be held prior to the issuance of the order proposing to 
reclassify a device. These commenters believed that our interpretation 
ignores the structure and language of FDASIA, undermines the panel 
protections Congress included in FDASIA to ensure that panels 
scrutinize the scientific and regulatory soundness of the proposed 
reclassification, and is inconsistent with our panel process in past 
part 860 proceedings.
    (Response 10) The FD&C Act, as amended by FDASIA, does not 
prescribe when the panel meeting and proposed order must occur in 
relation to each other. Therefore, the Agency may hold a panel meeting 
either before or after the issuance of a proposed reclassification 
order. This approach is consistent with the FDA practice before FDASIA, 
which allowed FDA, at its discretion, to secure a panel recommendation 
prior to the

[[Page 64451]]

promulgation of a reclassification rule. Prior to FDASIA, when a panel 
meeting was discretionary, FDA often held a panel meeting before 
proposing reclassification of the device. Generally, for future 
reclassifications when a meeting of a device classification panel has 
not yet occurred, FDA intends to issue a proposed reclassification 
order before holding the panel meeting if the panel is required.
    (Comment 11) Some comments objected to FDA communications with 
individual panel members by telephone or by mail and alleged that such 
communications amount to Agency ex parte communications and do not 
support transparency, stakeholder involvement, or the opportunity to 
present supporting or opposing information. One comment requested that 
consultation by mail should either be removed or used only if a panel 
meeting is infeasible and the circumstances require prompt decisions to 
protect the public health.
    (Response 11) The Agency agrees that every effort should be made to 
consult with an entire classification panel when possible, and that an 
adequate record of such consultation is essential. However, there will 
be circumstances in which statutory time constraints, the necessity to 
protect the public health, the request by the petitioner for a timely 
response, or the unavailability of panel members will require the 
Commissioner to consult by telephone with at least a majority of 
current voting panel members. Regardless of the method of consultation 
with panel members, the Agency conducts panel meetings in accordance 
with part 14 (21 CFR part 14), which includes record keeping and public 
participation.
    The reference to panel ``consultation by mail'' in the current part 
860 regulations is removed (Sec.  860.125(a)(2), removed by this final 
rule). The Agency intends to continue its past practice, however, of 
using postal mail, other delivery services, and electronic email to 
deliver documents to panel members for the purpose of distributing them 
at FDA's option in advance of and following panel consultations, at 
attended meetings, or in telephone- or video-conference sessions.
    (Comment 12) One comment requested that FDA operate panels under 
the rules of the Federal Advisory Committee Act (FACA), Public Law 92-
464 (1972), as amended, in order to ensure transparency and stakeholder 
input, specifically, that panel members should be required to disclose 
financial and nonfinancial conflicts of interests and that FDA should 
address any conflicts in a prompt and consistent manner.
    (Response 12) The Agency conducts panel meetings in accordance with 
the FACA and part 14 to provide for transparency through a public 
meeting where stakeholders can be part of the Agency's decision-making 
process. Meetings are open to all members of the public and include an 
open public hearing (OPH) portion where the public can participate. 
Federal Register notices are used by the Agency to announce meetings 
and to provide information on how the public can request to present in 
the OPH. The pertinent Agency guidance document provides further 
information on public participation in the OPH (Ref. 2). Meeting 
announcements and meeting materials are available on the Agency's 
website. As outlined in the FD&C Act, classification panels are exempt 
from FACA section 14 pertaining to the duration of the panel (sections 
513(e)(1), 513(f)(3)(B), 515(b), and 520(l)(2) of the FD&C Act; see 
also section 513(b)(1) of the FD&C Act).
    Panelists are also subject to the financial disclosure provisions 
of the Ethics in Government Act of 1978, Public Law 95-521, as amended, 
and its implementing regulations (5 U.S.C. App. 101 et seq.; 5 CFR part 
2634, subpart I). These requirements apply to ``special government 
employees'' and regular government employees throughout the Federal 
Government, including panelists of FDA's classification panels 
(Sec. Sec.  14.1(a)(2)(vi) and 14.31). Panelists have to disclose 
financial interests on Form FDA 3410 (Confidential Financial Disclosure 
Report for Special Government Employees) that FDA reviews. If a current 
disqualifying financial interest exists for which a waiver may be 
granted, such waiver is disclosed on FDA's website prior to the date of 
the advisory committee meeting to which the waiver applies providing 
the type, nature, and magnitude of the financial interest (21 U.S.C. 
379d-1(c), see 18 U.S.C. 208(b)). Questions 2 and 3 of Form FDA 3410 
address past interests as well as anything that may give an appearance 
of a conflict of interest (5 CFR 2635.502). Financial disclosures 
provided by special government employees or regular government 
employees ``shall be confidential and shall not be disclosed to the 
public'' (5 U.S.C. App. 107).
3. Unique Device Identifier (UDI) Related Issues
    The UDI final rule establishing FDA's unique device identification 
system provided for implementation of UDI requirements over a 7-year 
period beginning in 2014 according to a schedule of compliance dates 
based primarily on device classification (78 FR 58785, September 24, 
2013). Among other things, FDA's regulations require a device to bear a 
UDI on its label and packages unless an exception or FDA-approved 
alternative applies (21 CFR 801.20). A finished device manufactured and 
labeled prior to the applicable compliance date for the device is 
excepted from the requirement to bear a UDI for a period of 3 years 
after that compliance date (21 CFR 801.30(a)(1)).
    (Comment 13) A comment requested the Agency to allow supply chain 
stakeholders at least 3 years to comply with the UDI labeling 
requirements following the reclassification of any medical device under 
the part 860 regulations as amended by this final rule, in order to 
assure consistency with the UDI final rule, which grants a 3-year grace 
period, for stakeholders to exhaust existing inventories of finished 
devices labeled prior to the applicable UDI compliance date.
    (Response 13) To the extent that a reclassification would affect 
the UDI compliance dates or UDI labeling requirements (21 CFR part 801, 
subpart B) applicable to a device, FDA will consider whether additional 
time to come into compliance with those UDI requirements is appropriate 
on a case-by-case basis.
    (Comment 14) The same commenter requested FDA to review its 
existing and proposed rules for medical device tracking and reporting, 
as well as the requirements of the proposed rule, for inconsistencies 
and discrepancies with the UDI compliance schedule and its 3-year grace 
period. Specifically, the commenter stated that FDA should assess and 
include in this final rule measures to relieve the logistical 
challenges facing distributors and end users who are required to make 
labeling, tracking, and reporting changes resulting from 
reclassifications under the part 860 regulations and affecting products 
distributed commercially prior to, but resold after, the device 
reclassification.
    (Response 14) This rulemaking, as described previously, finalizes 
changes to part 860 to conform to FDASIA amendments to the FD&C Act for 
the processes for reclassification and calling for PMAs and does not 
affect the UDI requirements. Further, any impact of device 
reclassifications on device compliance with requirements for device 
labeling (part 801), including the UDI labeling requirements (part 801, 
subpart B), for device tracking

[[Page 64452]]

requirements (21 CFR part 821), and for device reporting requirements 
(21 CFR part 803), will be addressed on a case-by-case basis.

E. Comments and FDA Response on Removal of Petition Requirements: 
Classification Questionnaire and Supplemental Data Sheet

    The final rule removes the requirement to provide two forms, Form 
FDA 3429 (General Device Classification Questionnaire) and Form FDA 
3427 (Supplemental Data Sheet), as part of the form and content of a 
reclassification petition, because the Agency no longer finds the forms 
useful (amended Sec. Sec.  860.3, 860.84, and 860.123 of this final 
rule, removing current Sec. Sec.  860.3(f) and (g), 860.84(c)(3) and 
(4), and 860.123(a)(3) and (4)).
    (Comment 15) Several comments disagreed with the Agency's proposal 
to remove Forms FDA 3427 and 3429 as filing requirements for petitions 
seeking the classification of preamendments devices (proposed Sec.  
860.84) and for petitions for the reclassification of postamendments 
devices (proposed Sec.  860.123). They argued that the forms provide a 
valuable framework for classification panels and are informative 
materials for panelists, and that not providing the information 
contained in the forms will decrease panel efficiency, prejudice the 
petitioner, and bias the part 860 classification and reclassification 
processes. The comments acknowledged that the forms are inadequate, but 
these commenters recommended that the forms should be improved, rather 
than eliminated.
    (Response 15) We disagree. As stated in our proposed rule, we 
believe that a more efficient use of FDA and petitioner resources would 
be to focus on the detailed, rather than summarized, information that 
the petitioner, FDA, panelists, and the public provide in the 
proceeding concerning available valid scientific evidence about the 
device and the appropriate regulatory controls to provide reasonable 
assurance of the safety and effectiveness of the device. Additionally, 
on January 30, 2017, the President directed FDA and other Agencies of 
the U.S. Government to identify existing regulations to be repealed 
and, in accordance with the APA and other applicable law when issuing 
new regulations, to eliminate existing regulatory costs so that the 
incremental cost of new regulations, when offset by the eliminated 
costs, would be zero or minimized (Executive Order (E.O.) 13771, 82 FR 
9339). The economic and regulatory burden associated with Forms FDA 
3427 and 3429 as filing requirements in the case of petitions seeking 
the reclassification of devices, and the cost savings from removing 
these requirements are estimated in the Paperwork Reduction Act (PRA) 
section of the proposed rule and in section VII, Economic Analysis of 
Impacts, and section X, PRA, of this final rule. This rule finalizes 
the provisions removing Forms FDA 3427 and 3429 from the part 860 
regulations, as proposed without change (amended Sec. Sec.  860.3, 
860.84 and 860.123 of this final rule, removing current Sec. Sec.  
860.3(f) and (g), 860.84(c)(3) and (4) and 860.123(a)(3) and (4)).

F. Comments on Other Proposed Conforming Changes and Technical 
Amendments to the Part 860 Regulations

1. Clarifying Amendments to Sec.  860.120(b)
    The part 860 regulations explain certain common criteria for 
reclassifying medical devices under the various authorities of the FD&C 
Act (Sec.  860.120(b), containing the general requirements for 
reclassifications under sections 513(e) and(f), 514(b) (21 U.S.C. 
360d(b)), 515(b), and 520(l) of the FD&C Act. The final rule removes 
the term ``substantial equivalence'' in the current version of this 
part 860 regulation, in order to clarify that reclassifying one device 
within a generic type of device reclassifies all devices within a 
generic type of device (amended Sec.  860.120(b) of this final rule).
    (Comment 16) Two comments questioned why, under proposed Sec.  
860.120(b), the impact of a reclassification decision applies to all 
devices within the same generic type. Commenters recommended that 
reclassification should instead be limited to those devices that are 
substantially equivalent to the reclassified device under question as 
provided in the current Sec.  860.120(b), because there may be some 
differences between devices within the same generic type of device that 
warrant different treatment by a reclassification decision. One 
commenter suggested that the final rule should provide that the scope 
of a reclassification decision will be determined based on the reason 
for the reclassification and the nature of the products affected by the 
reclassification decision.
    (Response 16) Through this rulemaking FDA is clarifying the impact 
of a reclassification decision under the FD&C Act and is not otherwise 
changing the scope of reclassifications made in accordance with this 
provision (see amended Sec.  860.120(b) of this final rule).
    The FD&C Act defines the term ``substantial equivalence'' to mean, 
with respect to a device compared to a predicate device, that FDA has 
found that the new device has the same intended use as the predicate, 
has the same technological characteristics as the predicate or 
different technological characteristics that do not raise different 
questions of safety and effectiveness from the predicate, and has been 
demonstrated to be as safe and effective as a legally marketed device 
(section 513(i) of the FD&C Act). In contrast, the current part 860 
regulations define the term ``generic type of device,'' specifically 
for classification purposes, as a grouping of devices that do not 
differ significantly in purpose, design, materials, energy sources, 
function, or any other feature related to safety and effectiveness, and 
for which similar regulatory controls are sufficient to provide 
reasonable assurance of safety and effectiveness (current Sec.  
860.3(i), not amended by this final rule). The term ``generic type of 
device'' is a more accurate term than ``substantial equivalence'' to 
describe the impact, scope, and analysis for a reclassification 
decision and as such we are finalizing the use of ``generic type of 
device'' as proposed. Accordingly, this rule also finalizes, as 
proposed, the removal of the reference elsewhere in the part 860 
regulations that limited the scope of reclassification to 
``substantially equivalent devices'' within the generic type of the 
reclassified device (amended Sec.  860.120(b) of this final rule).
2. Other Proposed Conforming Amendments
    We did not receive comments concerning any of the other proposed 
conforming amendments or any of the technical amendments described in 
the following paragraphs of this section. This rule finalizes all of 
these conforming and technical changes.
    The final rule substitutes the terms ``preamendments devices'' and 
``postamendments devices,'' in place of ``old devices'' and ``new 
devices,'' in the part 860 regulations to reflect modern FDA practice 
(amended Sec. Sec.  860.84 and 860.134 of this final rule).
    To assure uniform reclassification procedures for transitional 
devices under part 860, the final rule revises the pertinent part 860 
regulation to cover the process for reclassification initiated by FDA 
and to apply to reclassification initiated by manufacturer or importer 
(amended Sec.  860.136(a) and (b) of this final rule). The final rule 
also removes the requirement for a part 16 hearing when FDA is 
reclassifying transitional devices because we believe the

[[Page 64453]]

reclassification process under part 860 (i.e., proposed order, panel 
consultation as appropriate, consideration of comments, and final 
order) provides sufficient opportunity for participation and review of 
reclassifications of transitional devices (amended Sec.  860.136 of 
this final rule).
    The final rule revises some of the citations in the part 860 
regulations to clarify to which subsection in the FD&C Act these 
citations refer (amended Sec. Sec.  860.84(a), 860.123(b)(2), 860.134 
(in the section's title), and 860.134(b) of this final rule). Finally, 
the final rule also makes minor wording changes to certain part 860 
regulations to clarify the meaning of these provisions, which are not 
intended to make any substantive changes (amended Sec. Sec.  860.7(b), 
(c)(2), (d)(2), and (g)(1), 860.10(a), 860.120(c), 860.125(a)(2), 
860.130(g), and 860.132 of this final rule).

VI. Effective Date

    This final rule will become effective 90 days after the date of its 
publication in the Federal Register. During those 90 days, 
manufacturers will continue to be under an obligation to comply with 
all applicable provisions of the FD&C Act and applicable regulations.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under E.O. 12866, 
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
E.O.s 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). E.O. 13771 requires that 
the costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' We believe that this 
final rule is not a significant regulatory action as defined by E.O. 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. This final rule largely codifies existing FDA practices and 
clarifies the classification and reclassification procedures currently 
used. For these reasons, and because panel meetings, which represent 
the largest source of Agency and industry costs in this analysis, are 
one-time occurrences, we certify that the final rule will 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 $150 
million, using the most current (2017) 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.
    This final rule amends the regulations governing the process for 
classification, reclassification, and calling for PMAs for medical 
devices. It codifies existing provisions that are already in effect, 
and updates generally the regulations for device reclassification 
proceedings.
    The costs of this final rule include initial learning costs faced 
by medical device manufacturers and affiliated regulatory consultants 
upon publication of the rule, in addition to annual costs incurred by 
the Agency and industry related to preparation and participation in 
additional panel meetings. We estimate the rule's present discounted 
cost, over a 10-year period, to equal $2 million at a 3 percent 
discount rate and $1.7 million at a 7 percent discount rate. Our 
estimates of the annualized costs are $0.24 million at a 3 percent 
discount rate and $0.24 million at a 7 percent discount rate.
    The principal benefits of this final rule stem from the reduction 
in regulatory and economic burden that will accompany the elimination 
of some paperwork filing requirements, in addition to the enhanced 
consistency and uniformity across reclassification proceedings. These 
cost savings will accrue to both medical device manufacturers and to 
the Agency. Further benefits may be derived from the decreased time a 
petition will need to be reviewed for device reclassification, and the 
subsequent potential benefits realized by consumers and producers. We 
estimate the overall cost savings over the next 10 years to be $0.05 
million at a 3 percent discount rate and $0.04 million at a 7 percent 
discount rate. Our estimates of the annualized cost savings are $0.006 
million at a 3 percent discount rate and $0.006 million at a 7 percent 
discount rate.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Docket No. FDA-
2013-N-1529) and is included in the Final Regulatory Impact Analysis 
available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and (k) 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.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in E.O. 13175. We have determined that the rule does not contain 
policies that have a substantial direct effect on one or more Indian 
Tribes, on the relationship between the Federal Government and Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes. Accordingly, we conclude that 
the rule does not contain policies that have tribal implications as 
defined in the E.O. and, consequently, a tribal summary impact 
statement is not required.

X. 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 shown in the following paragraphs with an estimate of 
the annual reporting burden. 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: Reclassification Petitions for Medical Devices.
    Description: This rule eliminates the requirement for petitioners 
to complete Form FDA 3429 (Classification Questionnaire) and Form FDA 
3427 (Supplemental Data Sheet). The estimated information collection 
burdens for the forms are currently approved under OMB control number 
0910-0138.

[[Page 64454]]

    Description of Respondents: The reporting requirements referenced 
in this document are imposed on any person petitioning for 
reclassification of a preamendments device and any manufacturer or 
importer of the device petitioning for reclassification of a 
postamendments or transitional device.

                                                     Table 4--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition--Sec.   860.123......               6                1                6              497            2,982
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Section 860.123 is being amended to eliminate the requirement for 
petitioners to complete Form FDA 3429 (Classification Questionnaire) 
and Form FDA 3427 (Supplemental Data Sheet). This revision reduces the 
estimated burden by 18 hours. We expect modest cost savings and easing 
of economic and regulatory burden due to the reduction in time required 
in preparing and reviewing these forms.
    Based on current trends, FDA anticipates that six petitions will be 
submitted each year. The time required to prepare and submit a 
reclassification petition, including the time needed to assemble 
supporting data and to prepare the form, averages 497 hours per 
petition. This average is based upon estimates by FDA administrative 
and technical staff who are familiar with the requirements for 
submission of a reclassification petition, have consulted and advised 
manufacturers on these requirements, and have reviewed the 
documentation submitted.
    We received two comments on the proposed rule that are related to 
the information collection. Please see Comments 5 and 15 for a 
description of the comments and our response.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the PRA.
    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 and guidance. These collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 801, regarding labeling, have been 
approved under OMB control number 0910-0485; the collections of 
information in 21 CFR part 801, subpart B, regarding unique device 
identifier, have been approved under OMB control number 0910-0720; the 
collections of information in 21 CFR part 803, regarding medical device 
reporting, have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 807, subparts A through D, 
regarding establishment registration and listing, have been approved 
under OMB control number 0910-0625; the collections of information in 
21 CFR part 807, subpart E, regarding premarket notification, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, subparts A through E, regarding 
premarket notification, have been approved under OMB control number 
0910-0231; the collections of information in 21 CFR part 821, regarding 
medical device tracking, have been approved under OMB control number 
0910-0442; and the collections of information in the guidance document 
``De Novo Classification Process (Evaluation of Automatic Class III 
Designation)'' have been approved under OMB control number 0910-0844.

XI. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in E.O. 13132. We have determined that the final 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 final 
rule does not contain policies that have federalism implications as 
defined in the E.O. and, consequently, a federalism summary impact 
statement is not required.

XII. References

    The following references are on display at Dockets Management Staff 
(see ADDRESSES) 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 website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. ``Medical Device Classification Product Codes; Guidance for 
Industry and FDA Staff'' (April 2013), available at https://www.fda.gov/MedicalDevices/ucm285317.htm.
2. ``The Open Public Hearings at FDA Advisory Committee Meetings; 
Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff'' (May 2013), available at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm236144.pdf.
3. ``Final Regulatory Impact Analysis, Final Regulatory Flexibility 
Analysis, and Final Unfunded Mandates Reform Act Analysis for 
Medical Device Classification Procedures,'' available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 860

    Administrative practice and procedure, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
860 is amended as follows:

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
1. The authority citation for part 860 continues to read as follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.


Sec.  860.3  [Amended]

0
2. Amend Sec.  860.3 by removing and reserving paragraphs (f) and (g).

0
3. Amend Sec.  860.7 by revising paragraph (b) introductory text, the 
last sentence in paragraph (c)(2), paragraph (d)(2), and the last 
sentence in paragraph (g)(1) to read as follows:


Sec.  860.7  Determination of safety and effectiveness.

* * * * *

[[Page 64455]]

    (b) In determining the safety and effectiveness of a device for 
purposes of classification, establishment of special controls for class 
II devices, and premarket approval of class III devices, the 
Commissioner and the classification panels will consider the following, 
among other relevant factors:
* * * * *
    (c) * * *
    (2) * * * Such information may be considered, however, in 
identifying a device with questionable safety or effectiveness.
    (d) * * *
    (2) Among the types of evidence that may be required, when 
appropriate, to determine that there is reasonable assurance that a 
device is safe are investigations using laboratory animals, 
investigations involving human subjects, nonclinical investigations, 
and analytical studies for in vitro diagnostic devices.
* * * * *
    (g)(1) * * * The failure of a manufacturer or importer of a device 
to present to the Food and Drug Administration adequate, valid 
scientific evidence showing that there is reasonable assurance of the 
safety and effectiveness of the device, if regulated by general 
controls alone, or by general controls and special controls, may 
support a determination that the device be classified into class III.
* * * * *

0
4. Add Sec.  860.10 to read as follows:


Sec.  860.10  Implants and life-supporting or life-sustaining devices.

    (a) A classification panel will recommend classification into class 
III of any implant or life-supporting or life-sustaining device unless 
the panel determines that such classification is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device. If the panel recommends classification or reclassification of 
such a device into a class other than class III, it shall set forth in 
its recommendation the reasons for so doing and an identification of 
the risks to health, if any, presented by the device. In the case of 
such a device being recommended for classification or reclassification 
into class II, the panel shall describe the special controls that, in 
addition to general controls, the panel believes are necessary to 
provide reasonable assurance of safety and effectiveness of the device 
and how such controls provide such assurance.
    (b) The Commissioner will classify an implant or life-supporting or 
life-sustaining device into class III unless the Commissioner 
determines that such classification is not necessary to provide 
reasonable assurance of the safety and effectiveness of the device. If 
the Commissioner proposes to classify or reclassify such a device into 
a class other than class III, the regulation or order effecting such 
classification or reclassification will be accompanied by a full 
statement of the reasons for so doing. A statement of the reasons for 
not classifying or retaining the device in class III may be in the form 
of concurrence with the reasons for the recommendation of the 
classification panel, together with supporting documentation and data 
satisfying the requirements of Sec.  860.7 and an identification of the 
risks to health, if any, presented by the device. In the case of such a 
device being classified or reclassified into class II, the Commissioner 
shall describe the special controls that, in addition to general 
controls, the panel believes are necessary to provide reasonable 
assurance of safety and effectiveness of the device and how such 
controls provide such assurance.

0
5. Add Sec.  860.15 to read as follows:


Sec.  860.15  Exemptions from sections 510, 519, and 520(f) of the 
Federal Food, Drug, and Cosmetic Act.

    (a) A panel recommendation to the Commissioner that a device be 
classified or reclassified into class I will include a recommendation 
as to whether the device should be exempted from some or all of the 
requirements of one or more of the following sections of the Federal 
Food, Drug, and Cosmetic Act: Section 510 (registration, product 
listing, and premarket notification), section 519 (records and reports) 
and section 520(f) (good manufacturing practice requirements of the 
quality system regulation), and, in the case of a recommendation for 
classification into class II, whether the device should be exempted 
from the premarket notification requirement under section 510.
    (b) A regulation or an order classifying or reclassifying a device 
into class I will specify which requirements, if any, of sections 510, 
519, and 520(f) of the Federal Food, Drug, and Cosmetic Act the device 
is to be exempted from or, in the case of a regulation or an order 
classifying or reclassifying a device into class II, whether the device 
is to be exempted from the premarket notification requirement under 
section 510, together with the reasons for such exemption.
    (c) The Commissioner will grant exemptions under this section only 
if the Commissioner determines that the requirements from which the 
device is exempted are not necessary to provide reasonable assurance of 
the safety and effectiveness of the device.

0
6. Amend Sec.  860.84 by:
0
a. Revising the section heading and paragraph (a);
0
b. Removing the semicolon at the end of paragraph (c)(2) and adding ``; 
and'' in its place;
0
c. Removing paragraphs (c)(3) and (4);
0
d. Redesignating paragraph (c)(5) as paragraph (c)(3); and
0
e. Revising paragraphs (d)(2), (d)(4) through (6), (e), and (g)(2) and 
(3).
    The revisions read as follows:


Sec.  860.84  Classification procedures for ``preamendments devices.''

    (a) This subpart sets forth the procedures for the original 
classification of a generic type of device that was in commercial 
distribution before May 28, 1976. Such a device will be classified by 
regulation into either class I (general controls), class II (special 
controls) or class III (premarket approval), depending upon the level 
of regulatory control required to provide reasonable assurance of the 
safety and effectiveness of the device (Sec.  860.3(c)). This subpart 
does not apply to a device that is classified into class III by statute 
under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act 
because the Food and Drug Administration has determined that the device 
is not ``substantially equivalent'' to any device subject to this 
subpart or under section 520(l)(1) of the Federal Food, Drug, and 
Cosmetic Act because the device was regarded previously as a new drug. 
In classifying a preamendments device to which this section applies, 
the Food and Drug Administration will follow the procedures described 
in paragraphs (b) through (g) of this section.
* * * * *
    (d) * * *
    (2) A summary of the data upon which the recommendation is based;
* * * * *
    (4) In the case of a recommendation for classification into class 
I, a recommendation as to whether the device should be exempted from 
the requirements of one or more of the following sections of the 
Federal Food, Drug, and Cosmetic Act: Section 510 (registration, 
product listing, and premarket notification), section 519 (records and 
reports), and section 520(f) (good manufacturing practice requirements 
of the quality system regulation) and, in the case of a recommendation 
for classification into class II, whether the device should be exempted 
from the premarket notification requirement under section 510, in 
accordance with Sec.  860.15;

[[Page 64456]]

    (5) In the case of a recommendation for classification into class 
II or class III, to the extent practicable, a recommendation for the 
assignment to the device of a priority for the application of a 
performance standard or a premarket approval requirement, and in the 
case of classification into class II, a recommendation on the 
establishment of special controls and whether the device should be 
exempted from premarket notification in accordance with Sec.  860.15; 
and
    (6) In the case of a recommendation for classification of an 
implant or a life-supporting or life-sustaining device into class I or 
class II, a statement of why premarket approval is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device and an identification of the risks to health, if any, presented 
by the device, in accordance with Sec.  860.10.
    (e) A panel recommendation is regarded as preliminary until the 
Commissioner has reviewed it, discussed it with the panel if 
appropriate, and published a proposed regulation classifying the 
device. Preliminary panel recommendations are filed at Dockets 
Management Staff upon receipt and are available to the public at 
https://www.regulations.gov.
* * * * *
    (g) * * *
    (2) If classifying the device into class II, establish the special 
controls for the device and prescribe whether the premarket 
notification requirement will apply to the device; and
    (3) If classifying an implant, or a life-supporting or life-
sustaining device, comply with Sec.  860.10(b).

0
7. Add Sec.  860.90 to read as follows:


Sec.  860.90  Consultation with panels.

    (a) When the Commissioner is required to consult with a panel 
concerning a classification under Sec.  860.84, the Commissioner will 
consult with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members in a 
telephone or video conference call; or
    (2) Discussion at a panel meeting.
    (b) The method of consultation chosen by the Commissioner will 
depend upon the importance and complexity of the subject matter 
involved and the time available for action. When time and circumstances 
permit, the Commissioner will consult with a panel through discussion 
at a panel meeting.


Sec.  860.93  [Removed]

0
8. Remove Sec.  860.93.


Sec.  860.95  [Removed]

0
9. Remove Sec.  860.95.

0
10. Amend Sec.  860.120 by revising paragraphs (b) and (c) to read as 
follows:


Sec.  860.120  General.

* * * * *
    (b) The criteria for determining the proper class for a device are 
set forth in Sec.  860.3(c). The reclassification of any device within 
a generic type of device causes the reclassification of all devices 
within that generic type. Accordingly, a petition for the 
reclassification of a specific device will be considered a petition for 
reclassification of all devices within the same generic type.
    (c) Any interested person may submit a petition for 
reclassification under section 513(e), 514(b), or 515(b) of the Federal 
Food, Drug, and Cosmetic Act. A manufacturer or importer may submit a 
petition for reclassification under section 513(f) or 520(l) of the 
Federal Food, Drug, and Cosmetic Act. The Commissioner may initiate the 
reclassification of a device under the following sections of the 
Federal Food, Drug, and Cosmetic Act:
    (1) Section 513(e) (for a classified device other than a device 
classified into class III under section 513(f)(1) or 520(l)(1) of the 
Federal Food, Drug, and Cosmetic Act);
    (2) Section 513(f)(3) (for a device classified into class III under 
section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act); or
    (3) Section 520(l)(2) (for a device classified into class III under 
section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act).

0
11. Amend Sec.  860.123 by:
0
a. Removing paragraphs (a)(3) and (4);
0
b. Redesignating paragraphs (a)(5) through (10) as paragraphs (a)(3) 
through (8), respectively;
0
c. Removing the period at the end of newly redesignated paragraph 
(a)(7) and adding ``; and'' in its place; and
0
d. Revising paragraph (b)(2).
    The revision reads as follows:


Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (2) Marked clearly with the section of the Federal Food, Drug, and 
Cosmetic Act under which the petition is being submitted, i.e., 
``513(e),'' ``513(f)(3),'' ``514(b),'' ``515(b),'' or ``520(l) 
Petition'';
* * * * *

0
12. Amend Sec.  860.125 by:
0
a. Revising paragraphs (a) introductory text and (a)(1);
0
b. Removing paragraph (a)(2) and redesignating paragraph (a)(3) as 
paragraph (a)(2);
0
c. Redesignating paragraph (c) as paragraph (d);
0
d. Revising newly redesignated paragraph (d); and
0
e. Adding a new paragraph (c).
    The revisions and addition read as follows:


Sec.  860.125   Consultation with panels.

    (a) When the Commissioner chooses to refer a reclassification 
petition to a classification panel for its recommendation under Sec.  
860.134(b), or the Commissioner is required to consult with a panel 
concerning a reclassification petition submitted under Sec.  860.130(d) 
or received in a proceeding under Sec.  860.133(b), or the Commissioner 
chooses to consult with a panel with regard to the reclassification of 
a device initiated by the Commissioner under Sec.  860.134(c) or Sec.  
860.136, the Commissioner will distribute a copy of the petition, or 
its relevant portions, if applicable, to each panel member and will 
consult with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members in a 
telephone or video conference call; or
* * * * *
    (c) The Commissioner will consult with a classification panel prior 
to changing the classification of a device in a proceeding under 
section 513(e) of the Federal Food, Drug, and Cosmetic Act and Sec.  
860.130 upon the Commissioner's own initiative or upon petition of an 
interested person, and in the latter case, the Commissioner will 
distribute a copy of the petition, or its relevant portions, to each 
panel member.
    (d) When a petition is submitted under Sec.  860.134 for a 
postamendments, not substantially equivalent, device, if the 
Commissioner chooses to consult with the panel, the Commissioner will 
obtain a recommendation that includes the information described in 
Sec.  860.84(d). In consulting with a panel about a petition submitted 
under Sec.  860.130(d), Sec.  860.136(a), or received in a proceeding 
under Sec.  860.133(b), the Commissioner may or may not obtain a formal 
recommendation.

0
13. Amend Sec.  860.130 by revising the section heading and paragraphs 
(c) through (g) to read as follows:


Sec.  860.130  General procedures under section 513(e) of the Federal 
Food, Drug, and Cosmetic Act.

* * * * *

[[Page 64457]]

    (c) By administrative order published under this section, the 
Commissioner may change the classification from:
    (1) Class I or class II to class III if the Commissioner determines 
that the device meets the criteria set forth in Sec.  860.3(c)(3) for a 
class III device; or
    (2) Class III or class I to class II if the Commissioner determines 
that the device meets the criteria set forth in Sec.  860.3(c)(2) for a 
class II device; or
    (3) Class III or class II to class I if the Commissioner determines 
that the device meets the criteria set forth in Sec.  860.3(c)(1) for a 
class I device.
    (d)(1) The Commissioner shall consult with a classification panel 
and may secure a recommendation with respect to reclassification of a 
device from a classification panel. The panel will consider 
reclassification in accordance with the consultation procedures of 
Sec.  860.125. A recommendation submitted to the Commissioner by the 
panel will be published in the Federal Register when the Commissioner 
publishes an administrative order under this section.
    (2) The Commissioner may change the classification of a device by 
administrative order published in the Federal Register following 
publication of a proposed reclassification order in the Federal 
Register, a meeting of a device classification panel described in 
section 513(b) of the Federal Food, Drug, and Cosmetic Act, and 
consideration of comments to a public docket.
    (e) Within 180 days after the filing of a petition for 
reclassification under this section, the Commissioner will either deny 
the petition by order published in the Federal Register or give notice 
of the intent to initiate a change in the classification of the device.
    (f) If a device is reclassified under this section, the 
administrative order effecting the reclassification may revoke any 
special control or premarket approval requirement that previously 
applied to the device but that is no longer applicable because of the 
change in classification.
    (g) An administrative order under this section changing the 
classification of a device to class II may provide that such 
reclassification will not take effect until the effective date of a 
performance standard for the device established under section 514 of 
the Federal Food, Drug, and Cosmetic Act or other special controls 
established under the order. An order under this section changing the 
classification of a device to class II may also establish the special 
controls necessary to provide reasonable assurance of the safety and 
effectiveness of the device.

0
14. Amend Sec.  860.132 by:
0
a. Revising the section heading and paragraph (a);
0
b. Redesignating paragraph (b) as paragraph (d);
0
c. Revising newly redesignated paragraphs (d) introductory text and 
(d)(1) and (3); and
0
d. Adding new paragraphs (b) and (c).
    The revisions and additions read as follows:


Sec.  860.132  Procedures when the Commissioner initiates a performance 
standard or premarket approval proceeding under section 514(b) or 
515(b) of the Federal Food, Drug, and Cosmetic Act.

    (a) Sections 514(b) and 515(b) of the Federal Food, Drug, and 
Cosmetic Act require the Commissioner to provide, by notice in the 
Federal Register, an opportunity for interested parties to petition to 
change the classification of a device based upon new information 
relevant to its classification when the Commissioner initiates a 
proceeding to develop a performance standard for the device if in class 
II or to issue an order requiring premarket approval for the device if 
in class III.
    (b) If the Commissioner agrees that the new information submitted 
in response to a proposed order to require premarket approval of a 
device issued under section 515(b) of the Federal Food, Drug, and 
Cosmetic Act warrants a change in classification, the Commissioner 
shall follow the administrative order procedures under section 513(e) 
of the Federal Food, Drug, and Cosmetic Act and Sec.  860.130 to effect 
such a change.
    (c) If the Commissioner does not agree that the new information 
submitted in response to a proposed order to require premarket approval 
of a device issued under section 515(b) of the Federal Food, Drug, and 
Cosmetic Act warrants a change in classification, the Commissioner will 
deny the petition.
    (d) The procedures under section 514(b) of the Federal Food, Drug, 
and Cosmetic Act are as follows:
    (1) Within 30 days after publication of the Commissioner's notice 
referred to in paragraph (a) of this section, an interested person 
files a petition for reclassification in accordance with Sec.  860.123.
* * * * *
    (3) Within 60 days after publication of the notice referred to in 
paragraph (a) of this section, the Commissioner either denies the 
petition or gives notice of the intent to initiate a change in 
classification in accordance with Sec.  860.130.

0
15. Add Sec.  860.133 to read as follows:


Sec.  860.133  Procedures when the Commissioner initiates a proceeding 
to require premarket approval under section 515(b) of the Federal Food, 
Drug, and Cosmetic Act.

    (a) Section 515(b) of the Federal Food, Drug, and Cosmetic Act 
applies to proceedings to require premarket approval for a class III 
preamendments device.
    (b) The Commissioner may require premarket approval for a class III 
preamendments device by administrative order published in the Federal 
Register following publication of a proposed order in the Federal 
Register, a meeting of a device classification panel described in 
section 513(b) of the Federal Food, Drug, and Cosmetic Act, and 
consideration of comments from all affected stakeholders, including 
patients, payors, and providers. The panel will consider 
reclassification petitions received in the proceeding in accordance 
with section 513(e) of the Federal Food, Drug, and Cosmetic and the 
applicable consultation procedures in Sec.  860.125. A recommendation 
submitted to the Commissioner by the panel will be published in the 
Federal Register when the Commissioner publishes an administrative 
order under this section.

0
16. Amend Sec.  860.134 by:
0
a. Revising the section heading and paragraph (a)(3);
0
b. Removing the undesignated paragraph following paragraph (a)(3);
0
c. Adding paragraph (a)(4);
0
d. Revising paragraphs (b) introductory text and (b)(4) and (6); and
0
e. Adding paragraphs (c) and (d).
    The revisions and additions read as follows:


Sec.  860.134  Procedures for reclassification of ``postamendments 
devices'' under section 513(f)(3) of the Federal Food, Drug, and 
Cosmetic Act.

    (a) * * *
    (3) The Commissioner has classified the device into class I or 
class II in response to a petition for reclassification under this 
section; or
    (4) The device is classified under a request for De Novo 
classification under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The procedures for effecting reclassification under section 
513(f)(3) of the Federal Food, Drug, and Cosmetic Act when initiated by 
a manufacturer or importer are as follows:
* * * * *
    (4) Within 90 days after the date the petition is referred to the 
panel, following the review procedures set forth in Sec.  860.84(c) for 
the original classification of a ``preamendments

[[Page 64458]]

device'', the panel submits to the Commissioner its recommendation 
containing the information set forth in Sec.  860.84(d). A panel 
recommendation is regarded as preliminary until the Commissioner has 
reviewed it, discussed it with the panel, if appropriate, and developed 
a proposed reclassification order. Preliminary panel recommendations 
are filed at Dockets Management Staff upon receipt and are available to 
the public and posted at https://www.regulations.gov.
* * * * *
    (6) Within 90 days after the panel's recommendation is received 
(and no more than 210 days after the date the petition was filed), the 
Commissioner denies or approves the petition by order in the form of a 
letter to the petitioner. If the Commissioner approves the petition, 
the order will classify the device into class I or class II in 
accordance with the criteria set forth in Sec.  860.3(c) and subject to 
the applicable requirements of Sec.  860.10, relating to the 
classification of implants and life-supporting or life-sustaining 
devices, and Sec.  860.15, relating to exemptions from certain 
requirements of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    (c) By administrative order published under section 513(f)(3) of 
the Federal Food, Drug, and Cosmetic Act, the Commissioner may, on the 
Commissioner's own initiative, change the classification from class III 
under section 513(f)(1) either to class II, if the Commissioner 
determines that special controls in addition to general controls are 
necessary and sufficient to provide reasonable assurance of the safety 
and effectiveness of the device and there is sufficient information to 
establish special controls to provide such assurance, or to class I if 
the Commissioner determines that general controls alone would provide 
reasonable assurance of the safety and effectiveness of the device. The 
procedures for the reclassification proceeding under this paragraph (c) 
are as follows:
    (1) The Commissioner publishes a proposed reclassification order in 
the Federal Register seeking comment on the proposed reclassification.
    (2) The Commissioner may consult with the appropriate 
classification panel with respect to the reclassification of the 
device. The panel will consider reclassification in accordance with the 
consultation procedures of Sec.  860.125.
    (3) Following consideration of comments to a public docket and any 
panel recommendations or comments, the Commissioner may change the 
classification of a device by final administrative order published in 
the Federal Register.
    (d) An administrative order under this section changing the 
classification of a device from class III to class II may establish the 
special controls necessary to provide reasonable assurance of the 
safety and effectiveness of the device.

0
17. Amend Sec.  860.136 by:
0
a. Revising the section heading, paragraph (a), and paragraph (b) 
introductory text;
0
b. Removing paragraph (b)(3);
0
c. Redesignating paragraphs (b)(4) through (6) as paragraphs (b)(3) 
through (5), respectively;
0
d. Revising newly redesignated paragraph (b)(4); and
0
e. Adding paragraphs (c) and (d).
    The revisions and additions read as follows:


Sec.  860.136  Procedures for transitional products under section 
520(l) of the Federal Food, Drug, and Cosmetic Act.

    (a) Section 520(l)(2) of the Federal Food, Drug, and Cosmetic Act 
applies to reclassification proceedings initiated by the Commissioner 
or in response to a request by a manufacturer or importer for 
reclassification of a device currently in class III by operation of 
section 520(l)(1). This section applies only to devices that the Food 
and Drug Administration regarded as ``new drugs'' before May 28, 1976.
    (b) The procedures for effecting reclassification under section 
520(l) of the Federal Food, Drug, and Cosmetic Act when initiated by a 
manufacturer or importer are as follows:
* * * * *
    (4) Within 180 days after the petition is filed (where the 
Commissioner has determined it to be adequate for review), the 
Commissioner, by order in the form of a letter to the petitioner, 
either denies the petition or classifies the device into class I or 
class II in accordance with the criteria set forth in Sec.  860.3(c).
* * * * *
    (c) By administrative order, the Commissioner may, on the 
Commissioner's own initiative, change the classification from class III 
under section 520(l) of the Federal Food, Drug, and Cosmetic Act either 
to class II, if the Commissioner determines that special controls in 
addition to general controls are necessary and sufficient to provide 
reasonable assurance of the safety and effectiveness of the device and 
there is sufficient information to establish special controls to 
provide such assurance, or to class I if the Commissioner determines 
that general controls alone would provide reasonable assurance of the 
safety and effectiveness of the device. The procedures for the 
reclassification proceeding under this paragraph (c) are as follows:
    (1) The Commissioner publishes a proposed reclassification order in 
the Federal Register seeking comment on the proposed reclassification.
    (2) The Commissioner may consult with the appropriate 
classification panel with respect to the reclassification of the 
device. The panel will consider reclassification in accordance with the 
consultation procedures of Sec.  860.125.
    (3) Following consideration of comments to a public docket and any 
panel recommendations or comments, the Commissioner may change the 
classification of a device by final administrative order published in 
the Federal Register.
    (d) An administrative order under this section changing the 
classification of a device from class III to class II may establish the 
special controls necessary to provide reasonable assurance of the 
safety and effectiveness of the device.

    Dated: December 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-27015 Filed 12-13-18; 8:45 am]
BILLING CODE 4164-01-P