[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Rules and Regulations]
[Pages 64443-64458]
[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

Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

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

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]
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                                                                                Lower bound     Upper bound
                                                                   Primary (7%)        (7%)            (7%)
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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.
------------------------------------------------------------------------

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

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

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

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

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

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

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

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.

    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.

* * * * *

    (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;

    (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.

* * * * *

    (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

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