Rule2022-00501
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
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Published
January 13, 2022
Effective
February 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also updating Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.
Full Text
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<title>Federal Register, Volume 87 Issue 9 (Thursday, January 13, 2022)</title>
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[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2042-2045]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. FDA-2019-N-3101]
RIN 0910-AI10
Revised Procedures for the Announcement of Approvals and Denials
of Premarket Approval Applications and Humanitarian Device Exemption
Applications
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 the medical device regulations regarding
the procedures for the announcement of approvals and denials of
premarket approval applications (PMAs) and humanitarian device
exemption applications (HDEs). This final rule discontinues the
publication in the Federal Register after each quarter of a list of PMA
and HDE approvals and denials announced in that quarter. We will
continue to post approval and denial notices for PMAs and HDEs on FDA's
home page on the internet and will also continue to make available on
the internet and place on public display summaries of safety and
effectiveness data (SSED) for PMAs and summaries of safety and probable
benefit (SSPB) for HDEs. FDA is taking this action to improve the
efficiency of announcing approvals and denials of PMAs and HDEs and to
eliminate duplication in the current process for announcing this
information. We are also updating Agency contact information and
statutory references in certain sections of the PMA and HDE regulations
for purposes of accuracy, clarity, and consistency.
DATES: This rule is effective February 14, 2022.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
240-402-7500.
FOR FURTHER INFORMATION CONTACT:
For information concerning the final rule as it relates to devices
regulated by the Center for Biologics Evaluation and Research: Tami
Belouin, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911.
For information concerning the final rule as it relates to devices
regulated by the Center for Devices and Radiological Health: Joshua
Nipper, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2438, Silver
Spring, MD 20993-0002, 301-796-6524.
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. Background
A. Need for the Regulation
B. History of the Rulemaking
C. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Specific Comments and FDA Response
C. Comments Outside the Scope of This Rulemaking
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. Reference
I. Executive Summary
A. Purpose of the Final Rule
FDA is amending its medical device regulations regarding the
procedures for the announcement of approvals and denials of PMAs and
HDEs to discontinue the quarterly publication in the Federal Register
of a list of approvals and denials of both PMAs and HDEs. FDA will
continue to post approval and denial notices for PMAs and HDEs on FDA's
home page on the internet (<a href="https://www.fda.gov">https://www.fda.gov</a>) and will also continue
to make available on the internet and place on public display SSED for
PMAs and SSPB for HDEs. FDA is taking this action to improve the
efficiency of announcing approvals and denials of PMAs and HDEs and
eliminate duplication in the current process for announcing this
information. We are also updating Agency contact information and
statutory references in certain PMA and HDE regulations for purposes of
accuracy, clarity, and consistency.
B. Summary of the Major Provisions of the Final Rule
FDA is amending its regulations regarding the announcement
procedures for the approval and denial of PMAs and HDEs. FDA is
discontinuing publishing in the Federal Register after each quarter a
list of PMA and HDE approvals and denials announced for that quarter.
We will continue to post approval and denial notices for PMAs and HDEs
on FDA's home page on the internet, and we will also continue to make
SSED for PMAs and SSPB for HDEs available on the internet and place
them on public display.
C. Legal Authority
FDA is issuing this final rule under sections 515, 520(h), 520(m),
and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360e, 360j(h), 360j(m), and 371(a)).
D. Costs and Benefits
The benefit of this final rule is that it will result in cost
savings to FDA from discontinuing publishing in the Federal Register,
on a quarterly basis, a list of medical device PMA and HDE approvals
and denials. Annualized over 10 years, the estimated benefits (i.e.,
cost savings) to FDA range from $0.008 million to $0.013 million at
both 3 and 7 percent discount rate, with a primary estimate of $0.010
million. We estimate that this final rule will result in no additional
costs to industry because the
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rule will not require performance of any additional tasks and,
therefore, will not impose any additional regulatory burden on the
industry.
II. Background
A. Need for the Regulation
FDA is amending its medical device regulations regarding the
procedures for the announcement of approvals and denials of PMAs and
HDEs to discontinue the quarterly publication in the Federal Register
of a list of approvals and denials of both PMAs and HDEs. FDA is taking
this action to improve the efficiency of announcing approvals and
denials of PMAs and HDEs and eliminate duplication in announcing this
information. The final rule allows FDA staff to focus on other Agency
priorities and utilize FDA staff resources more efficiently. FDA is
also revising Sec. 814.44(d)(2) (21 CFR 814.44(d)(2)) to be consistent
with Sec. 814.45(d)(2) (21 CFR 814.45(d)(2)), which states that
requests for copies of the current PMA approvals and denials document
and copies of SSED must be sent in writing to FDA's Freedom of
Information Staff. In addition, FDA is updating outdated references to
section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec. 814.40 (21 CFR
814.40), 814.44, and 814.45) and HDE (Sec. 814.118 (21 CFR 814.118))
regulations.
B. History of the Rulemaking
Section 515(d)(4) of the FD&C Act permits an interested person to
obtain review of an order approving a PMA in accordance with section
515(g) of the FD&C Act. The statute does not require the Agency to
publish the approval of a PMA in the Federal Register; however, FDA
issued in the Federal Register of July 22, 1986 (51 FR 26342) a final
rule that provided, among other things, that notice of approval of a
PMA, notice of an order denying approval of a PMA, and notice of an
order withdrawing approval of a PMA will be published in the Federal
Register. In the Federal Register of June 26, 1996 (61 FR 33232), FDA
issued a final rule prescribing, among other things, the procedures for
submitting HDEs, HDE amendments, and HDE supplements, and the criteria
for FDA review and approval of HDEs. Furthermore, the final rule of
June 26, 1996, provided that the notice of approval of an HDE be
published in the Federal Register in accordance with the rules and
policies applicable to PMAs submitted under 21 CFR 814.20. That final
rule also provided that, if FDA issues an order denying approval of an
HDE, FDA will comply with the same notice and disclosure provisions
required for PMAs under Sec. 814.45(b) and (d), as applicable.
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
issued a final rule discontinuing the publication of individual PMA
approvals and denials in the Federal Register. The final rule provided
that FDA would notify the public of PMA approvals and denials by
posting them on FDA's home page on the internet, by making available on
the internet and placing on public display SSED, and by publishing in
the Federal Register after each quarter a list of the PMA approvals and
denials announced in that quarter. FDA stated that it believed that
this procedure would expedite public notification of these actions
because announcements could be placed on the internet more quickly than
they could be published in the Federal Register, and FDA believed that
the internet would be accessible to more people than the Federal
Register.
In the Federal Register of December 17, 2019 (84 FR 68829), FDA
published a proposed rule entitled ``Revised Procedures for the
Announcement of Approvals and Denials of Premarket Approval
Applications and Humanitarian Device Exemption Applications'' to
discontinue publishing in the Federal Register after each quarter a
list of PMA and HDE approvals and denials announced in that quarter. We
also proposed to update Agency contact information and statutory
references in certain sections of the PMA and HDE regulations for
purposes of accuracy, clarity, and consistency. After consideration of
the comments received, we are now finalizing the proposed rule without
change.
C. Summary of Comments to the Proposed Rule
We received comments on the proposed rule from individual
submitters. We received one comment in support of the proposed rule and
one comment against discontinuing the quarterly publication in the
Federal Register of a list of approvals and denials of PMAs and HDEs.
These comments are further summarized in section IV.
III. Legal Authority
We are issuing this final rule under the authority of sections 515,
520(h), and 520(m) of the FD&C Act, which set forth requirements for
device premarket approval, release of detailed summaries of information
respecting the safety and effectiveness of devices, and humanitarian
device exemptions, and under section 701(a) of the FD&C Act, which
provides FDA the authority to issue regulations for the efficient
enforcement of the FD&C Act.
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
We received comments on the proposed rule from individual
submitters. We describe and respond to the comments in sections IV.B
and C of this document. We have numbered each comment to help
distinguish between different comments. 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. Specific Comments and FDA Response
(Comment 1) One comment supported the proposed rule.
(Response 1) We acknowledge and appreciate the supportive comment.
(Comment 2) One comment opposed discontinuing the publication in
the Federal Register after each quarter of a list of PMA and HDE
approvals and denials announced in that quarter. The comment stated
that the Federal Register provides a complete, archivable, and
reviewable record of Federal Agency decisions, that the FDA website
does not provide. The comment further noted that the quarterly Federal
Register summary may be useful to persons searching for aggregate
trends in FDA actions.
(Response 2) We do not believe the quarterly Federal Register
notice is needed to provide an adequate record of PMA and HDE approvals
and denials. The Federal Register notice merely summarizes the
quarterly PMA and HDE approvals and denials; it does not provide
information on those approvals and denials beyond what can be obtained
in other formats on the FDA website. Additionally, we will continue to
give the public notice of PMA and HDE approvals and denials by placing
notices of approvals and denials on FDA's home page on the internet.
These notices, along with certain supporting documentation, are also
maintained and can be viewed online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Furthermore, we do not believe it is necessary to publish the
quarterly Federal Register notices as a search tool for ``aggregate
trends in FDA actions.'' We note that there are existing tools such as
FDA's searchable PMA database (<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm</a>) and HDE database (https://
[[Page 2044]]
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm; <a href="https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/premarket-approvals-and-humanitarian-device-exemptions-supporting-documents">https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/premarket-approvals-and-humanitarian-device-exemptions-supporting-documents</a>) that
the public can utilize to search for information on PMA and HDE
approvals over a certain period of time.
C. Comment Outside the Scope of This Rulemaking
(Comment 3) One comment questioned which products FDA evaluates
before they are sold.
(Response 3) We decline to respond because this comment is outside
the scope of this final rule.
V. Effective Date
This final rule will become effective 30 days after the date of its
publication in the Federal Register.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule will not impose any additional
regulatory burden on the industry, we certify that the 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 $158
million, using the most current (2020) 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.
The benefit of this final rule is that it will result in cost
savings to FDA from discontinuing publishing in the Federal Register,
on a quarterly basis, a list of approvals and denials of PMAs and HDEs.
Discontinuing publishing Federal Register notices with these approval
and denial lists will eliminate duplication in announcing this
information; information on these approvals and denials will continue
being readily available to the public on FDA's home page on the
internet (<a href="https://www.fda.gov">https://www.fda.gov</a>).
We estimate that this final rule will result in no additional costs
to industry because the rule will not require performance of any
additional tasks. The rule, therefore, will not impose any additional
regulatory burden on the industry.
Table 1 summarizes the estimated benefits and costs of the final
rule. Annualized over 10 years, the estimated benefits (i.e., cost
savings) of the final rule range from $0.008 million to $0.013 million
at both 3 and 7 percent discount rate, with a primary estimate of
$0.010 million. The present value of the estimated benefits (i.e. cost
savings) of the final rule ranges from $0.068 million to $0.111 million
at a 3 percent discount rate and from $0.056 million to $0.091 million
at a 7 percent discount rate. The annualized costs of the final rule
are $0 at both 3 and 7 percent discount rate. The present value of
costs of the final rule is also $0 at both 3 and 7 percent discount
rate.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
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Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
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Benefits:
Annualized Monetized $millions/ $0.010 $0.008 $0.013 2020 7 10 Benefits are cost savings.
year.
0.010 0.008 0.013 2020 3 10 Benefits are cost savings.
Annualized Quantified.
Qualitative.
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Costs:
Annualized Monetized $millions/ 0 0 0 2020 7 10
year.
0 0 0 2020 3 10
Annualized Quantified.
Qualitative.
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Transfers:
Federal Annualized Monetized
$millions/year.
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From/To........................... From:
To:
-----------------------------------------------------------------------------------------------------------------
Other Annualized Monetized
$millions/year.
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From/To........................... From:
To:
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Effects:
State, Local or Tribal Government: No significant effect............................................................................................
Small Business: No significant effect...............................................................................................................
Wages: N/A..........................................................................................................................................
Growth: N/A.........................................................................................................................................
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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 (Ref. 1) and at
<a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
VII. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
IX. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.
X. 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.
XI. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
1. FDA/Economics Staff, ``Revised Procedures for the Announcement of
Approvals and Denials of Premarket Approval Applications and
Humanitarian Device Exemption Applications, Regulatory Impact
Analysis, Regulatory Flexibility Analysis, Unfunded Mandates Reform
Act Analysis,'' 2020 (available at: <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>).
List of Subjects in 21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, 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
part 814 is amended as follows:
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
1. The authority citation for part 814 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
Sec. 814.40 [Amended]
0
2. In Sec. 814.40, remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
Sec. 814.44 [Amended]
0
3. Amend Sec. 814.44 as follows:
0
a. In the fourth sentence in paragraph (d)(1), remove ``515(d)(3)'' and
add in its place ``515(d)(4)'' and remove the sixth sentence;
0
b. In paragraph (d)(2), remove ``Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852'' and add in its place ``Freedom of Information
Staff's address listed on the Agency's website at <a href="https://www.fda.gov">https://www.fda.gov</a>.''; and
0
c. In paragraphs (e)(2)(ii) and (f)(2), remove ``515(d)(3)'' and add in
its place ``515(d)(4)''.
Sec. 814.45 [Amended]
0
4. Amend Sec. 814.45 as follows:
0
a. In paragraph (d)(1), remove the third sentence and
0
b. In paragraph (e)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
0
5. In Sec. 814.116 revise the fourth sentence in paragraph (b) to read
as follows:
Sec. 814.116 Procedures for review of an HDE.
* * * * *
(b) * * * The notice of approval of an HDE will be placed on the
FDA's home page on the internet (<a href="https://www.fda.gov">https://www.fda.gov</a>) in accordance
with the rules and policies applicable to PMAs submitted under Sec.
814.20. * * *
* * * * *
Sec. 814.118 [Amended]
0
6. In Sec. 814.118(c)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
Dated: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00501 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-P
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