Notice2021-28453
Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
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
January 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 1 (Monday, January 3, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Pages 93-94]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Request for Nominations on Public Advisory Panels of the Medical
Devices Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on certain panels of the
Medical Devices Advisory Committee (MDAC or Committee) in the Center
for Devices and Radiological Health (CDRH) notify FDA in writing. FDA
is also requesting nominations for nonvoting industry representatives
to serve on certain device panels of the MDAC in the CDRH. A nominee
may either be self-nominated or nominated by an organization to serve
as a nonvoting industry representative. Nominations will be accepted
for current and upcoming vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by
February 2, 2022 (see sections I and II of this document for further
details). Concurrently, nomination materials for prospective candidates
should be sent to FDA by February 2, 2022.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Margaret Ames (see
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives should be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal:
<a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a> or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993, 301-796-5960, email:
<a href="/cdn-cgi/l/email-protection#0568647762647760712b64686076456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="2a474b584d4b584f5e044b474f596a4c4e4b04424259044d455c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for
nonvoting industry representatives to the panels listed in the table in
this document.
I. Medical Devices Advisory Committee
The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, advises the Commissioner of Food and
Drugs (the Commissioner) regarding recommended classification or
reclassification of devices into one of three regulatory categories;
advises on any possible risks to health associated with the use of
devices; advises on formulation of product development protocols;
reviews premarket approval applications for medical devices; reviews
guidelines and guidance documents; recommends exemption of certain
devices from the application of portions of the FD&C Act; advises on
the necessity to ban a device; and responds to requests from the agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices. With the exception
of the Medical Devices Dispute Resolution Panel, each panel, according
to its specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices. The Committee also provides recommendations to the
Commissioner or designee on complexity categorization of in vitro
diagnostics under the Clinical Laboratory Improvement Amendments of
1988.
------------------------------------------------------------------------
Panels Function
------------------------------------------------------------------------
Circulatory System Devices Panel.. Reviews and evaluate data concerning
the safety and effectiveness of
marketed and investigational
devices for use in the circulatory
and vascular systems and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Obstetrics and Gynecology Devices Reviews and evaluates data
Panel. concerning the safety and
effectiveness of marketed and
investigational devices for use in
obstetrics and gynecology and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Radiological Devices Panel........ Reviews and evaluates data
concerning the safety and
effectiveness of marketed and
investigational diagnostic or
therapeutic radiological and
nuclear medicine devices and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
------------------------------------------------------------------------
II. Qualifications
Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer
[[Page 94]]
with one another and to select a candidate, within 60 days after the
receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for a particular device panel. The
interested organizations are not bound by the list of nominees in
selecting a candidate. However, if no individual is selected within 60
days, the Commissioner will select the nonvoting member to represent
industry interests.
IV. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nomination must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Committee Membership Nomination Portal
(see ADDRESSES) within 30 days of publication of this document (see
DATES). Nominations must also specify the advisory panel for which the
nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the particular device panels
listed in the table. (Persons who nominate themselves as nonvoting
industry representatives will not participate in the selection
process).
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28453 Filed 12-30-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 3, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.