Notice2022-03476
Device Good Manufacturing Practice Advisory Committee; Notice of Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee. The committee reviews regulations proposed for promulgation regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations to the Commissioner of Food and Drugs regarding the feasibility and reasonableness of those proposed regulations. The meeting will be open to the public.
Full Text
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<title>Federal Register, Volume 87 Issue 33 (Thursday, February 17, 2022)</title>
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[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Page 9066]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03476]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Device Good Manufacturing Practice Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Device Good
Manufacturing Practice Advisory Committee. The committee reviews
regulations proposed for promulgation regarding good manufacturing
practices governing the methods used in, and the facilities and
controls used for, the manufacture, packing, storage, and installation
of devices, and makes recommendations to the Commissioner of Food and
Drugs regarding the feasibility and reasonableness of those proposed
regulations. The meeting will be open to the public.
DATES: The meeting will take place virtually on March 2, 2022, from 9
a.m. to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: <a href="https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings</a>.
FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#074d66757568632944686b6b6e627547616366296f6f7429606871"><span class="__cf_email__" data-cfemail="aae0cbd8d8c5ce84e9c5c6c6c3cfd8eacccecb84c2c2d984cdc5dc">[email protected]</span></a>, 240-672-5763, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting. The meeting will be webcast and will be available at the
following links: YouTube (primary): <a href="https://youtu.be/SPrNfVb2Yv8">https://youtu.be/SPrNfVb2Yv8</a> and
TEAMS (captions): <a href="https://teams.microsoft.com/">https://teams.microsoft.com/</a>. Please log on 20
minutes before the webcast to test your signal. You may have to refresh
your browser before logging on.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. As required
by section 520(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(f)(1)(B)), on March 2, 2022, the committee
will discuss and make recommendations on the current good manufacturing
practice requirements for medical devices under 21 CFR part 820, the
Quality System Regulation, to align more closely with an international
consensus standard for medical devices used by other regulatory
authorities.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
and the link to the online teleconference meeting room will be
available at <a href="https://www.fda.gov/advisory-committees/medical-devices/device-good-manufacturing-practice-advisory-committee">https://www.fda.gov/advisory-committees/medical-devices/device-good-manufacturing-practice-advisory-committee</a>. Select the link
for the 2022 Meeting Materials. The meeting will include slide
presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 24, 2022. Oral presentations from the public will be scheduled
on March 2, 2022, between approximately 1:30 p.m. to 2:30 p.m. Eastern
Time. Those individuals interested in making formal oral presentations
should notify the contact person (see FOR FURTHER INFORMATION CONTACT).
The notification should include a brief statement of the general nature
of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
February 21, 2022. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by February 22,
2022.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#7a1c1e1b15171b3a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="e6808287898b87a6808287c88e8e95c8818990">[email protected]</span></a> or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at <a href="/cdn-cgi/l/email-protection#e1a08f8fac80938884cfb6888d8d88808c92a1878580cf898992cf868e97"><span class="__cf_email__" data-cfemail="85c4ebebc8e4f7ece0abd2ece9e9ece4e8f6c5e3e1e4abededf6abe2eaf3">[email protected]</span></a> or 301-796-
5966 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings</a> for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03476 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P
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