[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Rules and Regulations]
[Pages 31471-31478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10 and 800

[Docket No. FDA-2016-N-2378]
RIN 0910-AH37


Internal Agency Review of Decisions; Requests for Supervisory 
Review of Certain Decisions Made by the Center for Devices and 
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing a 
final rule to amend its regulations regarding internal agency 
supervisory review of certain decisions related to devices regulated by 
the Center for Devices and Radiological Health (CDRH or the Center) 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to 
the applicable provisions in the FD&C Act, as amended by the Food and 
Drug Administration Safety and Innovation Act (FDASIA) and the 21st 
Century Cures Act (Cures Act). This final rule codifies the procedures 
and timeframes for supervisory review of significant decisions 
pertaining to devices within CDRH. FDA is also finalizing regulations 
to provide new procedural requirements for requesting internal agency 
supervisory review within CDRH of other types of decisions made by CDRH 
not addressed in FDASIA and the Cures Act. This action is also part of 
FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under 
these EOs, FDA is comprehensively reviewing existing regulations to 
identify opportunities for repeal, replacement, or modification that 
will result in meaningful burden reduction, while allowing the Agency 
to achieve its public health mission and fulfill statutory obligations.

DATES: This rule is effective August 1, 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 the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the final rule: Adaeze 
Teme, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5574, Silver 
Spring, MD 20993-0002, 240-402-0768; or the Ombudsman for the Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 4282, Silver Spring, MD 20993-
0002, 301-796-5669, or CDRHOmbudsman@fda.hhs.gov.

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 Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of the 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 Comments and FDA Responses
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to implement regulations on the 
procedures regarding internal agency supervisory review of certain 
decisions made by CDRH under the FD&C Act. Section 603 of FDASIA (Pub. 
L. 112-144) added new section 517A to the FD&C Act (21 U.S.C. 360g-1), 
which was amended by sections 3051 and 3058 of the Cures Act (Pub. L. 
114-255). These provisions established procedures and timeframes for 
supervisory review under Title 21 of the Code of Federal Regulations 
(CFR) Sec.  10.75 (21 CFR 10.75) of significant decisions by CDRH 
pertaining to devices. After the enactment of FDASIA, FDA issued a 
guidance document entitled ``Center for Devices and Radiological Health 
Appeals Processes: Questions and Answers About 517A--Guidance for 
Industry and Food and Drug Administration Staff'' (Q&A Guidance) to 
provide interpretation of key provisions of section 517A of the FD&C 
Act, including those that pertain to requests for supervisory review of 
significant decisions by CDRH (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM352254.pdf). FDA is finalizing this regulation to codify: (1) The 
procedures and timeframes for Sec.  10.75 appeals of ``significant 
decisions'' by CDRH established under section 517A and (2) the 
interpretation of key provisions of section 517A of the FD&C Act 
regarding supervisory review. In addition, the regulations codify new 
procedural requirements for supervisory review within CDRH of other 
CDRH decisions that were not addressed in FDASIA and the Cures Act.
    The final rule provides transparency and clarity for internal and 
external stakeholders on CDRH's process for supervisory review of 
decisions and provides requesters new predictability through binding 
deadlines for FDA action on a request for supervisory review within 
CDRH and the Center's internal agency review of ``significant 
decisions.'' Furthermore, this final rule codifies the types of 
decisions that are considered ``significant decisions,'' for which the 
timeframes apply. The final regulations also codify the timeframe for 
submission of requests for the review of other decisions within CDRH.

[[Page 31472]]

B. Summary of the Major Provisions of the Final Rule

    FDA is amending part 10 (21 CFR part 10) by adding Sec.  10.75(e). 
Section 10.75 currently provides that an interested person outside the 
Agency may request internal agency review of a decision of an FDA 
employee. FDA is amending Sec.  10.75 to add paragraph (e) to require 
that requests for internal agency supervisory review of a decision 
within CDRH also comply with new Sec.  800.75 (21 CFR 800.75). This 
change to the regulations encompasses both significant decisions under 
section 517A of the FD&C Act and other decisions by CDRH employees for 
which review is requested through the supervisory chain within CDRH.
    The final rule also adds new Sec.  800.75 to part 800 (21 CFR part 
800). Section 800.75 incorporates in the regulations the provisions of 
section 517A of the FD&C Act for review of ``significant decisions'' 
related to devices regulated under the FD&C Act by CDRH. Section 800.75 
defines ``significant decisions.'' Section 800.75 also includes the 
timeframes for submission of requests for internal agency review of 
significant decisions within CDRH and for responses to such requests.
    Section 800.75 further addresses requests for supervisory review 
within CDRH of decisions other than section 517A decisions and 
indicates the timeframe for submission of these requests for internal 
agency review.

C. Legal Authority

    FDA's legal authority to implement requirements pertaining to the 
process and timelines for Sec.  10.75 appeals of decisions within CDRH 
derives from sections 510(k), 515, 515B, 517A, and 520(g) of the FD&C 
Act (21 U.S.C. 360(k), 360e, 360e-3, 360g-1, and 360j(g)) and other 
provisions under which a decision might be appealed, and 701(a) of the 
FD&C Act (21 U.S.C. 371(a)). Section 701(a) of the FD&C Act gives FDA 
general rulemaking authority to issue regulations for the efficient 
enforcement of the FD&C Act.

D. Costs and Benefits

    We expect the costs and benefits of the final rule will be 
negligible.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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             Abbreviation                        What it means
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510(k)...............................  Premarket notification.
513(f)(2)............................  De Novo classification process.
517A decision........................  A significant decision regarding
                                        a device as set forth in section
                                        517A of the FD&C Act.
Agency...............................  Food and Drug Administration.
CDRH or Center.......................  Center for Devices and
                                        Radiological Health.
CFR..................................  Code of Federal Regulations.
CLIA.................................  Clinical Laboratory Improvement
                                        Amendments, 42 U.S.C. 263a.
EO...................................  Executive Order.
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 603 of FDASIA.
HDE..................................  Humanitarian Device Exemption.
IDE..................................  Investigational Device Exemption.
Non-517A decision....................  CDRH decisions outside the scope
                                        of section 517A of the FD&C Act.
NSE..................................  Not substantially equivalent.
OMB..................................  Office of Management and Budget.
Part 10..............................  21 CFR part 10.
PMA..................................  Premarket approval.
PRA..................................  Paperwork Reduction Act of 1995,
                                        44 U.S.C. 3501-3520.
PHS Act..............................  Public Health Service Act.
Section 10.75........................  21 CFR 10.75.
U.S.C................................  United States Code.
We or us.............................  Food and Drug Administration.
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III. Background

A. Need for the Regulation/History of the Rulemaking

    FDA has long provided a path for outside parties to request 
internal agency review of decisions. A procedure for this type of 
review was first published as a proposed regulation in 1975 (40 FR 
40682, September 3, 1975). In the preamble for that proposed rule, the 
Agency recognized that a process for administrative review of Agency 
decisions would advise outside parties on how they should pursue 
matters that interest and concern them (40 FR 40682 at 40693). A final 
rule published in 1977 incorporated these provisions into the Code of 
Federal Regulations at Sec.  2.17 (21 CFR 2.17) (42 FR 4680, January 
25, 1977).
    These regulations provided that any decision of an FDA employee, 
other than the Commissioner, on any matter was subject to review by the 
employee's supervisor under any of the following circumstances: (1) At 
the request of the employee, (2) on the initiative of the supervisor, 
(3) at the request of any interested person outside of the Agency, or 
(4) as required by duly promulgated delegations of authority. The 
review shall be accomplished by consultation between the employee and 
the supervisor, by review of the administrative file, or both. The 
review shall ordinarily follow established Agency channels of 
supervision. Internal agency review shall be based on the data and 
information available in the administrative file. If an interested 
person presents new data or information not contained in the 
administrative file, then the matter shall be returned to the 
appropriate lower level within the Agency for a reevaluation based upon 
the new information (42 FR 4680 at 4707).
    The following year, in 1978, a proposed rule was published to 
reorganize and revise the Agency's administrative practices and 
procedures regulations (43 FR 51966, November 7, 1978). When the final 
rule for that action was published, the regulations for internal agency 
review were moved from Sec.  2.17 and redesignated as Sec.  10.75 (44 
FR 22318, April 13, 1979), where these regulations remain today.
    In 1998, Sec.  10.75 was amended to add provisions allowing a 
sponsor, applicant, or manufacturer of a drug or device to request 
review of a scientific controversy by an appropriate scientific 
advisory panel or advisory committee (63 FR 63978, November 18, 1998). 
Aside from the specific situation addressed by the amendment, the 
elements of internal agency review under Sec.  10.75 relating to who 
may request the review and the information on which the review must be 
based remained unchanged.
    Section 10.75 contains regulations that establish an orderly 
process for internal agency review of decisions, based on information 
in the FDA administrative file. Section 10.75 applies to requests for 
review of decisions made by any FDA employee, other than decisions by 
the Commissioner of Food and Drugs. Section 10.75 does not establish 
timelines for requests for Agency review or for the Agency to act upon 
these requests. The FDA guidance document entitled ``Center for Devices 
and Radiological Health Appeals Processes: Guidance for Industry and 
Food and Drug Administration Staff'' describes the Sec.  10.75 appeal 
processes available to outside stakeholders to request review of 
decisions or actions by CDRH employees (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf).
    On July 9, 2012, the FD&C Act (21 U.S.C. 301 et seq.) was amended 
by FDASIA. Section 603 of FDASIA added new section 517A to the FD&C 
Act, which specifies procedures and timeframes for the supervisory 
review of significant decisions pertaining to devices regulated by 
CDRH.
    On December 13, 2016, the FD&C Act was further amended by the Cures 
Act. Section 3051 of the Cures Act, ``Breakthrough Devices,'' added 
section 515B to the FD&C Act (as amended by

[[Page 31473]]

section 901(f)(2) of the FDA Reauthorization Act of 2017 (Pub. L. 115-
52)) and amended section 517A(a)(1) to include any significant decision 
by CDRH regarding a request for designation as a breakthrough device 
under section 515B.
    In addition, section 3058, ``Least Burdensome Device Review,'' of 
the Cures Act amended section 517A(a) by adding paragraph (3), which 
requires that the substantive summary include a brief statement of how 
the least burdensome requirements were considered and applied 
consistent with sections 513(i)(1)(D), 513(a)(3)(D), and 515(c)(5) of 
the FD&C Act (21 U.S.C. 360c(i)(1)(D), 360c(a)(3)(D), and 360e(c)(5)), 
as applicable.
    Section 517A of the FD&C Act provides that any person may request a 
supervisory review of any significant decision of CDRH regarding the 
submission or review of a report under section 510(k), an application 
under section 515, a request for designation under section 515B, or an 
application for an exemption under section 520(g) of the FD&C Act. Any 
person may request such review, which may be conducted at the next 
supervisory level or higher above the individual who made the 
significant decision. Where the request for supervisory review was made 
at the organizational level, any person may request a supervisory 
review to the next organizational level or higher above the level at 
which the decision was made. In addition, the Office or Center Director 
may designate a subordinate to be their representative, as the 
authority for a request made to that level. In this situation, a 
request for review heard by a designated subordinate is rendered on 
behalf of the Director and constitutes a review by that level of the 
organization.
    Section 517A of the FD&C Act includes specific timeframes both for 
the person requesting review and for FDA to respond to such a request. 
A request for review of a significant decision is required to be 
submitted to FDA not later than 30 days after such decision. In 
responding to this request, if the requester seeks an in-person meeting 
or a teleconference review, FDA is required to schedule the requested 
interaction not later than 30 days after the request is made. FDA is 
required to issue a decision not later than 30 days after the 
interaction, or, in the case of a person who does not seek an in-person 
meeting or teleconference review, FDA is required to issue a decision 
no later than 45 days after the request for supervisory review is 
received by FDA. An exception to the timeframes related to scheduling 
an in-person meeting or teleconference review, and to FDA's decision on 
a request for supervisory review of the significant decision, is 
provided in cases that are referred to experts outside of FDA. Although 
the procedures and timeframes in section 517A of the FD&C Act apply to 
an initial request for supervisory review of a significant decision by 
CDRH, CDRH has chosen to enhance transparency and predictability and 
apply those procedures and timeframes as well to sequential requests 
for supervisory review of significant decisions that are submitted to 
CDRH.
    On January 17, 2018, FDA published a proposed rule to incorporate 
the procedures and timeframes in section 517A of the FD&C Act to an 
initial or sequential request for supervisory review within CDRH of 
``significant decisions'' by CDRH into FDA's regulations (83 FR 2388). 
The proposed regulation also introduced new procedural requirements for 
requests for supervisory review within CDRH under Sec.  10.75 of 
decisions that do not fall under ``significant decisions'' under 
section 517A of the FD&C Act. We are finalizing this rule as described 
below.
1. Amendments to Sec.  10.75
    Part 10 is amended to add Sec.  10.75(e). FDA is adding language to 
clarify that requests by interested persons outside the Agency for 
internal agency review of a decision within CDRH must also comply with 
new Sec.  800.75. The amendments to Sec.  10.75(e) are not limited to 
significant decisions under section 517A of the FD&C Act. Rather, Sec.  
10.75(e) also encompasses supervisory review within CDRH of decisions 
other than 517A decisions made by CDRH.
2. New Sec.  800.75
    Section 517A of the FD&C Act establishes procedural requirements, 
including timeframes for a request for internal agency review of a 
``significant decision'' by CDRH. ``Significant decision'' is not 
defined in the statutory provision. FDA defines ``significant 
decision'' in Sec.  800.75 to provide greater clarity regarding which 
decisions fall within this statutory term.
    A ``517A decision'' is defined as a significant decision made by 
CDRH, as set forth in section 517A of the FD&C Act. We use the term 
``517A decision'' rather than the term ``significant decision'' because 
we do not want to imply that any other decisions of CDRH that do not 
fall within section 517A of the FD&C Act are not significant. 
Similarly, we do not use the term ``non-significant decision'' when 
speaking of decisions outside of the scope of section 517A, as that 
might imply some unintended assessment on our part concerning the 
importance of these types of decisions. In addition, because we include 
regulatory decisions by CDRH in addition to those set forth in section 
517A of the FD&C Act, we believe that this will avoid any confusion 
that might occur in distinguishing between these two categories of 
decisions. For these reasons, we instead are using the term ``517A 
decision'' for those decisions that are identified under section 517A 
as significant decisions and refer to other decisions by CDRH as ``non-
517A decisions.''
    The review procedures under section 517A of the FD&C Act apply only 
to a request for review of a significant decision by CDRH regarding 
submission or review of a report under section 510(k) (Premarket 
Notification), an application under section 515 (Premarket Approval 
Application (PMA)/Humanitarian Device Exemption (HDE)), a request for 
designation under section 515B (Breakthrough Devices), or an 
application for an exemption under section 520(g) of the FD&C Act 
(Investigational Device Exemption (IDE)). Under the new Sec.  800.75, 
only the following decisions are considered significant decisions under 
section 517A of the FD&C Act and, thus, defined for purposes of this 
rule as ``517A decisions'':
     510(k): Not substantially equivalent; Substantially 
equivalent.
     PMA/HDE: Not approvable; Approvable; Approval; Denial.
     Breakthrough Device Designation Request (request for 
breakthrough designation for devices subject to premarket notification, 
premarket approval, or De Novo classification process (see 
``Breakthrough Devices Program: Guidance for Industry and FDA Staff''; 
available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm581664.pdf): Grant; Denial of request 
for breakthrough designation.
     IDE: Disapproval; Approval.
     Failure to reach agreement on protocol under section 
520(g)(7) of the FD&C Act.
     ``Clinical Hold'' determinations under section 520(g)(8) 
of the FD&C Act.
    We are mindful that outside parties may use Sec.  10.75 to request 
review of decisions other than 517A decisions. For this reason, we 
provided procedural requirements for internal agency supervisory review 
within CDRH under Sec.  10.75 of non-517A decisions made by CDRH 
employees. A request for supervisory review of a CDRH decision other 
than a 517A decision is to be received no later than 60 days after the

[[Page 31474]]

date of the decision that is subject to review. Any request received 
after 60 days in these cases will be denied as untimely, unless CDRH, 
for good cause related to circumstances beyond the control of the 
submitter, such as snow emergency, Federal Government shutdown, or 
other unforeseen emergency event, permits the request to be filed after 
60 days.
    Section 800.75 provides that requests for CDRH review of 517A 
decisions and non-517A decisions must be addressed to the next 
organizational level or higher above the individual who made the 
decision. Requests to elevate the review of such decisions should 
include a rationale. The decision to collapse two or more levels of 
review or to elevate a review would solely be at CDRH's discretion. In 
addition, requesters should have exhausted review through the 
supervisory chain below the Center Director level prior to request for 
review at the Center Director level.
    As provided in the FDA guidance entitled ``eCopy Program for 
Medical Device Submissions: Guidance for Industry and Food and Drug 
Administration Staff'' (eCopy guidance), appeals to submission types 
identified under section 745A(b) of the FD&C Act are subject to the 
electronic format requirements (available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf). Therefore, Sec.  10.75 requests for supervisory review 
of 517A decisions within CDRH, and certain decisions other than 517A 
decisions, must be submitted in accordance with section 745A(b) of the 
FD&C Act and the standards established by the eCopy guidance, when 
applicable. In addition, requests for breakthrough designation under 
section 515B of the FD&C Act for devices under sections 510(k), 
513(f)(2), and 515(c) of the FD&C Act would be considered 
``presubmissions'' to those submission types as identified under 
section 745A, and, therefore, requests for breakthrough designation 
would be subject to section 745A(b) of the FD&C Act, and likewise, 
Sec.  10.75 requests for review within CDRH.
    Further, Sec.  800.75 requires that requests for supervisory review 
of CDRH decisions other than 517A decisions be sent to the CDRH 
Ombudsman, and if subject to section 745A of the FD&C Act, are to be 
submitted in electronic format.

B. Summary of Comments in Response to the Proposed Rule

    The comments on the proposed rule were generally favorable and 
supportive of the proposal to codify the procedures and timeframes for 
supervisory review of 517A and non-517A decisions pertaining to devices 
regulated by CDRH.
    A comment appreciated the Agency's actions to clarify the CDRH 
process for supervisory review of decisions along with deadlines for 
certain FDA actions. Another comment, however, requested clarification 
about escalating review beyond the next organizational level above the 
decision maker (telescoping review). Another comment questioned whether 
the scope of significant decisions under section 517A of the FD&C Act 
should be expanded; specifically, recognition of additional CDRH 
decisions as 517A decisions. A comment was received on clarifying 
timeframes for receipt of a substantive summary upon request as 
required for a 517A decision. The comment also expressed concern over 
the proposed timeframe for requests for supervisory review of non-517A 
decisions, requested clarification on specific timeframes for non-517A 
decisions for requesters that seek to schedule a meeting or 
teleconference, and requested the addition of timeframes for when CDRH 
will render a decision.

IV. Legal Authority

    We are issuing this final rule to codify the procedures and 
timeframes in section 517A of the FD&C Act, added by section 603 of 
FDASIA and amended by the Cures Act, for Sec.  10.75 appeals of 
``significant decisions'' regarding the submission or review of a 
report under section 510(k), an application under section 515, a 
request for designation under section 515B, or an application for an 
exemption under section 520(g) of the FD&C Act.
    We are also finalizing additional procedural requirements for Sec.  
10.75 appeals submitted to CDRH of other types of CDRH decisions not 
addressed in FDASIA and the Cures Act.
    FDA's legal authority to implement requirements pertaining to the 
process and timelines for Sec.  10.75 appeals submitted to CDRH derives 
from sections 510(k), 515, 515B, 517A, and 520(g) of the FD&C Act and 
other provisions under which a decision might be appealed, and 701(a) 
of the FD&C Act. Section 701(a) of the FD&C Act gives FDA general 
rulemaking authority to issue regulations for the efficient enforcement 
of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received various comments from a trade organization and an 
individual on the proposed rule by the close of the comment period; 
however, only one commenter provided comments on issues relevant to the 
proposed rule.
    We describe and respond to the comments below. 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 topic is purely for organizational purposes 
and does not signify the comment's value or importance.

B. Description of Comments and FDA Responses

    (Comment 1) One comment appreciates FDA's efforts to provide 
clarity to industry on the CDRH process for supervisory review of 
decisions, along with binding deadlines for certain FDA actions related 
to supervisory review and other related timeframes.
    (Response 1) FDA proposed the regulation to provide clarity on the 
process for supervisory review and instruction on how external 
stakeholders, who disagree with a decision or action taken by CDRH, may 
seek resolution. FDA believes a well-informed process for CDRH reviews 
of significant decisions under 517A of the FD&C Act, as well as non-
517A decisions, promotes consistency, predictability, efficiency, and a 
transparent pathway of our review process.
    (Comment 2) A comment requested that FDA expand the definition of 
significant decision as set forth in section 517A of the FD&C Act by 
including: (1) a grant or denial of Clinical Laboratory Improvement 
Amendments (CLIA) waiver and a (2) grant or decline of a De Novo 
classification request.
    (Response 2a) When Congress passed CLIA in 1988 (Pub. L. 100-578), 
amending section 353 of the Public Health Service (PHS) Act (42 U.S.C. 
263a), they established clinical laboratory quality standards for all 
laboratory testing. While the Centers for Medicare & Medicaid Services 
has primary responsibility for administering CLIA, FDA also has certain 
responsibilities under CLIA, including categorizing tests as high 
complexity, moderate complexity, or waived. However, Congress did not 
include CLIA waived categorization under the PHS Act as regulatory 
decisions that trigger the requirements under section 517A of the FD&C 
Act. Therefore, FDA does not intend to expand the definition of a 
significant decision to the grant or denial of a CLIA waiver because it 
is outside the scope of the types of

[[Page 31475]]

decisions expressly included under section 517A of the FD&C Act.
    (Response 2b) FDA recognizes that the De Novo classification 
process is an important part of our regulatory framework. In accordance 
with section 513(f)(2)(A)(i) of the FD&C Act, any person who submits a 
510(k) for a type of device that has not been previously classified 
under the FD&C Act, and that is classified into class III, may request, 
after receiving written notice of such classification, FDA to classify 
the device based on the criteria set forth in section 513(a)(1) of the 
FD&C Act. Under section 513(f)(2)(A)(ii) 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 based on the criteria set forth in section 513(a)(1) of the 
FD&C Act without first submitting a 510(k). The process created by 
section 513(f)(2) of the FD&C Act, which was added by the Food and Drug 
Administration Modernization Act of 1997 (Pub. L. 105-115) and referred 
to therein as the Evaluation of Automatic Class III Designation, is 
what is now referred to as the De Novo classification process. Although 
the decision to grant or decline a De Novo request is within FDA's 
regulatory authority, it is not a decision type identified in section 
517A of the FD&C Act as a significant decision. Because section 517A of 
the FD&C Act does not identify decisions on requests under section 513 
of the FD&C Act as one of the types of significant decisions subject to 
section 517A, FDA believes that a De Novo request appropriately remains 
within the regulatory category of a non-517A decision.
    (Comment 3) One comment requested that FDA permit the collapsing of 
two or more levels of review, which is otherwise referred to as 
``telescoped review'' to support assessment at the appropriate level 
and, alternatively, recommended emphasizing that requesters should 
exhaust review through the supervisory chain below the Center Director 
level prior to request for review at the Center Director level, absent 
adequate rationale.
    (Response 3) FDA has recognized that CDRH preserves ``telescoped 
review'' as a discretionary action in matters pertaining to regulatory 
issues, new policy questions, or highly complex scientific questions. 
As explained in the guidance entitled ``Center for Devices and 
Radiological Health Appeals Processes: Guidance for Industry and Food 
and Drug Administration Staff,'' engagement of a next-level supervisor 
in a matter under dispute does not necessarily disqualify the next-
level supervisor from hearing the dispute on appeal; however, elevation 
of a dispute may be appropriate if the next-level supervisor has been 
significantly and substantively involved in the regulatory action under 
review. Certain circumstances may also warrant referral of the review 
directly to the next-level supervisor, up to and including the Center 
Director. In these situations, the Center intends that the review will 
be undertaken and decided by the next-level supervisor. For example, 
circumstances such as imminent risk to public health may warrant 
elevation of a Division-level appeal directly to the Center Director. A 
stakeholder wishing to elevate a dispute should indicate a request for 
telescoped review with an accompanying rationale. The decision to 
collapse two or more levels of review or to elevate a review is made 
solely at the Center's discretion and the Center intends to document 
the rationale for the decision in the review decision letter.
    Absent approval for ``telescoped review,'' requesters must exhaust 
review through the supervisory chain below the Center Director level 
prior to requesting review at the Center Director level.
    (Comment 4) A comment requested clarification on the timeframe for 
receipt of a substantive summary and requested that FDA allow 
additional time to request supervisory review following a company's 
receipt of a substantive summary under section 517A of the FD&C Act.
    (Response 4) In accordance with section 517A(a) of the FD&C Act, 
FDA shall furnish, upon request, a substantive summary of the 
scientific and regulatory rationale for any significant decision 
regarding a report under section 510(k), an application under section 
515, a request under section 515B, or an application under section 
520(g) of the FD&C Act, to the person who is seeking to submit, or who 
has submitted, such report or application. The substantive summary must 
include documentation of significant controversies or differences of 
opinion and the resolution of such controversies or differences of 
opinion for any such significant decision of CDRH, as well as a brief 
statement of how least burdensome requirements were considered and 
applied consistently with sections 513(i)(1)(D), 513(a)(3)(D), and 
515(c)(5) of the FD&C Act, as applicable.
    CDRH prepares and furnishes the final decision, as well as the 
substantive summary of the scientific and regulatory rationale, solely 
on the basis of the information in the administrative record, including 
in a report under section 510(k), an application under 515, a request 
for designation under 515B, or an application for an exemption under 
520(g) of the FD&C Act. Therefore, both the substantive summary and the 
final decision rely upon the same information in the administrative 
record, including the information submitted by the sponsor or 
applicant.
    Additionally, CDRH provides the information necessary to file an 
appeal in its final decision rendered for one of these reports or 
applications, including CDRH's rationale for the decision. In other 
words, the sponsor or applicant has the requisite information needed to 
submit an appeal in accordance with the timelines designated in the 
statute or identified as part of this final rule. While the substantive 
summary may include additional information, such as documentation of 
significant controversies or differences of opinion and the resolution 
of such, if applicable, that additional information is not necessary to 
file an appeal. Nonetheless, CDRH is committed to its current practice 
of furnishing the request for a substantive summary in a timely manner.
    (Comment 5) Another comment suggested that FDA update the final 
rule to include the following: (1) Revise the deadline for requests for 
supervisory review of non-517A decisions from 60 to 90 days and, in the 
alternative and (2) further clarify the meaning of ``good cause'' as 
well as expand ``good cause'' to include matters pertaining to public 
health and other justifications.
    (Response 5a) Although section 517A of the FD&C Act does not 
require FDA to implement procedures regarding CDRH decisions other than 
for 517A decisions, we are mindful that outside parties may use Sec.  
10.75 to request review of non-517A decisions. For this reason, we 
proposed that a request for supervisory review of a CDRH decision other 
than a 517A decision is to be received no later than 60 days after the 
date of the decision. Any request received after 60 days in these cases 
will be denied as untimely absent good cause.
    We believe 60 days is timely and appropriate for submission of a 
request for supervisory review of a non-517A decision. We note that 
this timeframe is twice as long as that for submission of a request for 
supervisory review of a 517A decision. The primary purpose regarding 
the deadline of a request for supervisory review of non-517A decisions 
in this final rule is to provide predictability, and to ensure that 
such requests are filed in a timely manner.

[[Page 31476]]

We believe that the timely filing of such requests within the 60-day 
timeframe will aid CDRH in efficiently handling disputes of non-517A 
decisions. However, expanding the 60-day timeframe for a request for 
supervisory review of a non-517A decision may negatively impact other 
decisions on CDRH regulated medical products. For example, a longer 
deadline may delay actions and resolutions of other pending matters 
that may be interrelated. This could negatively affect FDA's ability to 
act timely in fulfilling its mission to protect and promote the public 
health. For these reasons, we believe 60 days is an appropriate and 
reasonable timeframe.
    (Response 5b) On the occasion of an unforeseen emergency event, FDA 
will consider the basis for causes beyond the control of the submitter. 
As such, FDA may permit the request for supervisory review of a non-
517A decision to be filed after 60 days for good cause related to a 
snow emergency, Federal Government shutdown, or other unforeseen 
emergency event. We believe that good cause related to ``other 
unforeseen emergency event'' can include issues impacting public 
health. If a request for supervisory review of a non-517A decision is 
filed after 60 days, FDA will consider whether there is good cause for 
extending the timeline based on the circumstances.
    (Comment 6) A comment requested that FDA provide specific timelines 
for non-517A decisions related to when CDRH will schedule a meeting or 
teleconference, if requested by the person requesting supervisory 
review and when CDRH will render a decision if no teleconference or 
meeting is requested.
    (Response 6) We disagree that timelines for these actions are 
needed for FDA to provide timely responses for supervisory review of 
non-517A decisions. This final rule does not negatively affect CDRH's 
current practice of providing timely responses regarding requests for 
supervisory review of non-517A decisions. Apart from this rulemaking, 
we continue to work with industry and welcome stakeholder feedback on 
how to improve our communication regarding how CDRH will respond to an 
appeal of an adverse non-517A decision.

VI. Effective Date

    This rule will become effective 30 days after its publication in 
the Federal Register.

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. Because we lack information about the number of firms 
affected and because the affected firms will incur minimal costs to 
read and understand the rule, 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 proposing ``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 $154 million, using the most current (2018) 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.
    In our preliminary regulatory impact analysis, we estimated that 
the costs and benefits of the rule would be negligible. We received no 
comments on our preliminary regulatory impact analysis of the proposed 
rule and thus retain our original estimate for the final regulatory 
impact analysis. Because the final rule does not change the effort 
needed to prepare and submit a request for supervisory review, we 
anticipate that affected firms will incur only negligible costs to read 
and learn about the provisions of the final rule. The final rule will 
clarify the supervisory review process. However, we do not expect 
additional costs for FDA.

VIII. Analysis of Environmental Impact

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

IX. Paperwork Reduction Act of 1995

    This final rule contains previously approved information 
collections found in FDA regulations and guidance. These collections of 
information 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 collections of information regarding the appeals process for 
devices in the guidance document entitled ``Center for Devices and 
Radiological Health Appeals Processes'' have been approved under OMB 
control number 0910-0738; the collections of information in 21 CFR part 
807, subpart E (premarket notification) have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
812 (investigational device exemption) have been approved under OMB 
control number 0910-0078; the collections of information in 21 CFR part 
814, subparts A through E (premarket approval) have been approved under 
OMB control number 0910-0231; the collections of information in 21 CFR 
part 814, subpart H (humanitarian use devices) have been approved under 
OMB control number 0910-0332; the collections of information regarding 
``Requests for Feedback on Medical Device Submissions'' have been 
approved under OMB control number 0910-0756; 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; the collections of information 
regarding ``Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices: Guidance or Industry and Food and Drug 
Administration Staff'' have been approved under OMB control number 
0910-0598; and the collections of information regarding 
``Administrative Procedures for CLIA Categorization: Guidance for 
Industry and Food and Drug Administration Staff'' have been approved 
under OMB control number 0910-0607.

[[Page 31477]]

X. Federalism

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

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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 Executive Order and, consequently, a 
tribal summary impact statement is not required.

List of Subjects

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
10 and 800 are amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.


0
2. In Sec.  10.75, add paragraph (e) to read as follows:


Sec.  10.75  Internal agency review of decisions.

* * * * *
    (e) Each request by an interested person for review of a decision 
within the Center for Devices and Radiological Health shall also comply 
with Sec.  800.75 of this chapter.

PART 800--GENERAL

0
3. The authority citation for part 800 is revised to read as follows:

    Authority: 5 U.S.C. 551-559; 21 U.S.C. 301-399f.


0
4. Add Sec.  800.75 to subpart C to read as follows:


Sec.  800.75  Requests for supervisory review of certain decisions made 
by the Center for Devices and Radiological Health.

    (a) Definitions. The following definitions shall apply to this 
section:
    (1) FDA means the Food and Drug Administration.
    (2) 517A decision means a significant decision made by the Center 
for Devices and Radiological Health, as set forth in section 517A of 
the Federal Food, Drug, and Cosmetic Act, and includes one of the 
following decisions:
    (i) A substantially equivalent order under Sec.  807.100(a)(1) of 
this chapter, or a not substantially equivalent order under Sec.  
807.100(a)(2) of this chapter;
    (ii) An approval order under Sec.  814.44(d) of this chapter, an 
approvable letter under Sec.  814.44(e) of this chapter, a not 
approvable letter under Sec.  814.44(f) of this chapter, or an order 
denying approval under Sec.  814.45 of this chapter;
    (iii) An approval order under Sec.  814.116(b) of this chapter, an 
approvable letter under Sec.  814.116(c) of this chapter, a not 
approvable letter under Sec.  814.116(d) of this chapter, or an order 
denying approval under Sec.  814.118 of this chapter;
    (iv) A grant or denial of a request for breakthrough device 
designation under section 515B of the Federal Food, Drug, and Cosmetic 
Act;
    (v) An approval order under Sec.  812.30(a) of this chapter or a 
disapproval order under Sec.  812.30(c) of this chapter;
    (vi) A failure to reach agreement letter under section 520(g)(7) of 
the Federal Food, Drug, and Cosmetic Act; or
    (vii) A clinical hold determination under section 520(g)(8) of the 
Federal Food, Drug, and Cosmetic Act.
    (3) CDRH means the Center for Devices and Radiological Health.
    (b) Submission of request--(1) Review of 517A decisions. (i) An 
initial or sequential request for supervisory review within CDRH of a 
517A decision under Sec.  10.75 of this chapter must be addressed to 
the next organizational level or higher above the individual who made 
the decision; submitted in electronic format in accordance with section 
745A(b) of the Federal Food, Drug, and Cosmetic Act; marked ``Appeal: 
Request for Supervisory Review''; and received by CDRH no later than 30 
days after the date of the decision involved. Any such request for 
supervisory review not received by CDRH within 30 days after the date 
of the decision involved is not eligible for review. Except as provided 
in paragraph (b)(1)(ii) or (iii) of this section, FDA will render a 
decision within 45 days of the request for supervisory review.
    (ii) A person requesting supervisory review under paragraph 
(b)(1)(i) may request an in-person meeting or teleconference with the 
supervisor reviewing the request for supervisory review. Except as 
provided in paragraph (b)(1)(iii) of this section, if a request for in-
person meeting or teleconference is included in the request for 
supervisory review to CDRH, CDRH will schedule the meeting or 
teleconference to occur within 30 days of receipt of the request. 
Except as provided in paragraph (b)(1)(iii) of this section, a decision 
will be rendered within 30 days of such meeting or teleconference.
    (iii) The timeframes for CDRH to render a decision provided in 
(b)(1)(i) and (ii) of this section, and the timeframe to schedule an 
in-person meeting or teleconference review in (b)(1)(ii) of this 
section, do not apply if a matter related to the 517A decision under 
review is referred by CDRH to external experts, such as an advisory 
committee, as provided in Sec.  10.75(b) of this chapter.
    (2) Supervisory review. An initial or sequential request for 
supervisory review within CDRH under Sec.  10.75 of this chapter of a 
decision other than a 517A decision that is not received by CDRH within 
60 days after the date of the decision involved will be denied as 
untimely, unless CDRH, for good cause, permits the request to be filed 
after 60 days. An initial or sequential request for supervisory review 
within CDRH of a decision other than a 517A decision must be addressed 
to the next organizational level or higher above the individual who 
made the decision; submitted in electronic format in accordance with 
section 745A(b) of the Federal Food, Drug, and Cosmetic Act, when 
applicable; marked, ``Appeal: Request for Supervisory Review'' in the 
subject line of the electronic request; and sent to the CDRH Ombudsman 
at CDRHOmbudsman@fda.hhs.gov.


[[Page 31478]]


    Dated: June 20, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: June 25, 2019.

Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-14096 Filed 7-1-19; 8:45 am]
BILLING CODE 4164-01-P


