[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34691-34692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12176]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1138]
Effects of the COVID-19 Public Health Emergency on Formal
Meetings and User Fee Applications for Medical Devices--Questions and
Answers (Revised); Withdrawal of Guidance
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of the guidance document entitled ``Effects of the
COVID-19 Public Health Emergency on Formal Meetings and User Fee
Applications for Medical Devices--Questions and Answers (Revised),''
which was issued in June 2020 (and updated December 2020). FDA is
withdrawing this guidance document in recognition that the conditions
that created the need for these policies have evolved, such that these
policies are no longer needed.
DATES: The withdrawal date is July 7, 2022.
FOR FURTHER INFORMATION CONTACT: 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, 301-796-5640,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
As part of FDA's commitment to providing timely guidance to support
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in June 2020, the Agency published this guidance
document (June 23, 2020 at 85 FR 34638) and updated it in December
2020, to recognize that the COVID-19 public health emergency was
affecting the public health in numerous direct and indirect ways,
including device development programs.\2\ This guidance document
answered frequently asked questions and implemented temporary policies
to reduce industry burden.
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\1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
\2\ The term ``device(s)'' in this document refers to devices
regulated by the Center for Devices and Radiological Health (CDRH)
as well as devices regulated by the Center for Biologics Evaluation
and Research (CBER), including devices regulated as biological
products under section 351 of the Public Health Service (PHS) Act.
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FDA has continually assessed the needs and circumstances related to
these temporary policies, and as relevant needs and circumstances
evolved, the Agency made updates and modifications to these temporary
policies. FDA has determined that the needs and circumstances related
to the temporary policies described in the guidance document have
evolved, such that they are no longer needed, and the guidance document
should be withdrawn. In weighing the current burden to industry and the
Agency relating to the COVID-19 response efforts with the need to
ensure patients have timely access to new devices, FDA is withdrawing
this guidance document. Below is a brief description of the guidance
document and temporary policies that will be withdrawn:
The guidance articulated FDA's policy that for marketing
submissions and applications on hold, FDA did not intend to consider a
submission or application to be withdrawn for an additional 180 days
beyond the relevant response date. Returning to pre-pandemic policies
for marketing submissions and applications placed on hold after the
withdrawal of this guidance means FDA will generally consider the
submission or application to be withdrawn if the submitter or applicant
does not provide a complete response to major deficiency letters for
Premarket Approval Applications (PMAs) (original and supplements) \3\
and Humanitarian Device Exemption (HDE) applications (original and
supplements) \4\ within 360 days or to additional information letters
for 510(k) \5\ and De Novo requests \6\ within
[[Page 34692]]
180 days, consistent with preexisting guidance.
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\3\ For more information, please see the FDA guidance document
entitled ``FDA and Industry Actions on Premarket Approval
Applications (PMAs): Effect on FDA Review Clock and Goals'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals).
\4\ For more information, please see the FDA guidance document
entitled ``Humanitarian Device Exemption (HDE) Program'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program).
\5\ For more information, please see the FDA guidance document
entitled ``FDA and Industry Actions on Premarket Notification
(510(k)) Submissions: Effect on FDA Review Clock and Goals''
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-and-goals).
\6\ For more information, please see the FDA guidance document
entitled ``FDA and Industry Actions on De Novo Classification
Requests: Effect on FDA Review Clock and Goals'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals).
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When the COVID-19 public health emergency began, FDA understood
that applicants may face challenges affecting their ability to meet
their applicable response date for submissions placed on hold. FDA also
recognized our potential difficulty in processing a high volume of
individual extension requests on a timely basis. To alleviate these
concerns, the guidance document articulated that FDA did not intend to
consider an application or submission to be withdrawn for an additional
180 days beyond the relevant response date, regardless of whether the
applicant submitted an extension request.
By weighing the current burdens on industry with FDA's interest in
patients receiving timely access to new devices, FDA has determined it
is in the interest of the public health to return to pre-pandemic
policies regarding hold times. Reverting to policies regarding hold
times described in the preexisting guidance documents should facilitate
more timely premarket review of innovative and potentially lifesaving
devices. In addition, closing out files that have been abandoned in a
timelier manner allows for better management of the device review
program. The Agency acknowledges that the circumstances giving rise to
the public health emergency declaration for the COVID-19 pandemic
continue to exist. However, the conditions that created the need for
these policies have evolved, such that these policies are no longer
needed, and it is in the best interest of patients and providers to
reinstitute the original hold times to ensure patients have timely
access to advanced technologies, diagnostics, and therapeutics without
unnecessary delay.
The guidance document also discussed FDA's ability to host advisory
committee meetings virtually and FDA's intention to work with relevant
stakeholders to host all advisory committee meetings virtually. In
returning to pre-pandemic policies, FDA will assess the appropriate
venue for advisory committee meetings, keeping in mind FDA's successful
implementation of virtual advisory committee meetings. Consistent with
existing policy, the venue will be announced via the Federal Register.
Therefore, after careful review of current Agency processes,
industry practices with regard to resolving submission deficiencies,
and comments submitted to the public docket associated with the
guidance, FDA is withdrawing the ``Effects of the COVID-19 Public
Health Emergency on Formal Meetings and User Fee Applications for
Medical Devices--Questions and Answers (Revised)'' guidance in its
entirety.
II. Withdrawal Date
The withdrawal date for the guidance document discussed in this
document is July 7, 2022. For submissions or applications that receive
a major deficiency letter for PMA and HDE applications or additional
information letters for 510(k) and De Novo requests prior to or on the
guidance withdrawal date, FDA does not intend to consider the
submission or application to be withdrawn for an additional 180 days
beyond the relevant response date. For submissions or applications that
receive a major deficiency letter or additional information letter
after the guidance withdrawal date, FDA will generally consider the
application or submission to be withdrawn if a complete response is not
received by the relevant response date identified in that letter.
Authority: 21 U.S.C. 371(h).
Dated: June 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12176 Filed 6-3-22; 8:45 am]
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