[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75000-75002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0008]


Request for Nominations on Public Advisory Panels of the Medical 
Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) 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 the 
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 
December 1, 2023 (see sections I and II of this document for further 
details). Concurrently, nomination materials for prospective candidates 
should be sent to FDA by December 1, 2023.

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: 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

[[Page 75001]]


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#94d9f5e6f3f5e6f1e0bad5f9f1e7d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="a4e9c5d6c3c5d6c1d08ae5c9c1d7e4c2c0c58accccd78ac3cbd2">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for 
nonvoting industry representatives to the panels listed in table 1.

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 of the Medical Devices 
Advisory Committee 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.

                      Table 1--Panels and Functions
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             Panels                              Function
------------------------------------------------------------------------
Dental Products Panel...........  Reviews and evaluates data concerning
                                   the safety and effectiveness of
                                   marketed and investigational products
                                   for use in dentistry, endodontics, or
                                   bone physiology relative to the oral
                                   and maxillofacial area and makes
                                   appropriate recommendations to the
                                   Commissioner.
Ear, Nose, and Throat Devices     Reviews and evaluate data concerning
 Panel.                            the safety and effectiveness of
                                   marketed and investigational ear,
                                   nose, and throat devices and makes
                                   appropriate recommendations to the
                                   Commissioner.
General and Plastic Surgery       Reviews and evaluate data concerning
 Devices Panel.                    the safety and effectiveness of
                                   marketed and investigational general
                                   and plastic surgery devices and makes
                                   appropriate recommendations to the
                                   Commissioner.
Hematology and Pathology Devices  Reviews and evaluates data concerning
 Panel.                            the safety and effectiveness of
                                   marketed and investigational in vitro
                                   devices for use in clinical
                                   laboratory medicine including
                                   pathology, hematology,
                                   histopathology, cytotechnology, and
                                   molecular biology and makes
                                   appropriate recommendations to the
                                   Commissioner.
Orthopedic and Rehabilitation     Reviews and evaluates data concerning
 Devices Panel.                    the safety and effectiveness of
                                   marketed and investigational
                                   orthopedic and rehabilitation devices
                                   and makes appropriate recommendations
                                   to the Commissioner.
------------------------------------------------------------------------

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 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 table 1. (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

[[Page 75002]]

U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24123 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P


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