82 FR 45298 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 187 (September 28, 2017)

Page Range		45298-45299
FR Document		2017-20778

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.

Federal Register, Volume 82 Issue 187 (Thursday, September 28, 2017)

[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45298-45299]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


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 
October 30, 2017 (see sections I and II of this document for further 
details). Concurrently, nomination materials for prospective candidates 
should be sent to FDA by October 30, 2017.

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 Web site 
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Workforce 
Management, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver 
Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: 
[email protected].

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 (the 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 evaluates 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.
Clinical Chemistry and Clinical     Reviews and evaluates data
 Toxicology Devices Panel.           concerning the safety and
                                     effectiveness of marketed and
                                     investigational in vitro devices
                                     for use in clinical laboratory
                                     medicine including clinical
                                     toxicology, clinical chemistry,
                                     endocrinology, and oncology and
                                     makes appropriate recommendations
                                     to the Commissioner of Food and
                                     Drugs.
Gastroenterology and Urology        Reviews and evaluates data
 Devices Panel.                      concerning the safety and
                                     effectiveness of marketed and
                                     investigational gastroenterology,
                                     urology, and nephrology devices and
                                     makes appropriate recommendations
                                     to the Commissioner of Food and
                                     Drugs.
General Hospital and Personal Use   Reviews and evaluates data
 Devices Panel.                      concerning the safety and
                                     effectiveness of marketed and
                                     investigational general hospital,
                                     infection control, and personal use
                                     devices 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.

[[Page 45299]]

 
Ophthalmic Devices Panel..........  Reviews and evaluates data
                                     concerning the safety and
                                     effectiveness of marketed and
                                     investigational devices for use in
                                     the eye 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 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. Contact information, a current curriculum vitae, and 
the name of the panel of interest should be sent to the FDA Advisory 
Committee Membership Nomination Portal (see ADDRESSES) within 30 days 
of publication of this document (see DATES). 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: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20778 Filed 9-27-17; 8:45 am]
 BILLING CODE 4164-01-P

45298 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices

5630 Fishers Lane, Rm. 1061, Rockville, upcoming vacancies effective with this the panels listed in the table in this
MD 20852, and is available for viewing notice. document.
by interested persons between 9 a.m. DATES: Any industry organization I. Medical Devices Advisory Committee
and 4 p.m., Monday through Friday. interested in participating in the
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, selection of an appropriate nonvoting The Committee reviews and evaluates
‘‘Developing Drugs for Developing member to represent industry interests data on the safety and effectiveness of
Countries,’’ Health Affairs, vol. 25, no. 2, must send a letter stating that interest to marketed and investigational devices
pp. 313–324, 2006. the FDA by October 30, 2017 (see and makes recommendations for their
Dated: September 22, 2017. sections I and II of this document for regulation. The panels engage in a
further details). Concurrently, number of activities to fulfill the
Anna K. Abram,
nomination materials for prospective functions the Federal Food, Drug, and
Deputy Commissioner for Policy, Planning,
candidates should be sent to FDA by Cosmetic Act (the FD&C Act) envisions
Legislation, and Analysis.
October 30, 2017. for device advisory panels. With the
[FR Doc. 2017–20799 Filed 9–27–17; 8:45 am]
ADDRESSES: All statements of interest exception of the Medical Devices
BILLING CODE 4164–01–P
from industry organizations interested Dispute Resolution Panel, each panel,
in participating in the selection process according to its specialty area, advises
of nonvoting industry representative the Commissioner of Food and Drugs
DEPARTMENT OF HEALTH AND
nomination should be sent to Margaret (the Commissioner) regarding
HUMAN SERVICES
Ames (see FOR FURTHER INFORMATION recommended classification or
Food and Drug Administration CONTACT). All nominations for reclassification of devices into one of
nonvoting industry representatives three regulatory categories; advises on
should be submitted electronically by any possible risks to health associated
[Docket No. FDA–2017–N–0001]
accessing the FDA Advisory Committee with the use of devices; advises on
Request for Nominations on Public Membership Nomination Portal: https:// formulation of product development
Advisory Panels of the Medical www.accessdata.fda.gov/scripts/FACT protocols; reviews premarket approval
Devices Advisory Committee RSPortal/FACTRS/index.cfm or by mail applications for medical devices;
to Advisory Committee Oversight and reviews guidelines and guidance
AGENCY: Food and Drug Administration, Management Staff, Food and Drug documents; recommends exemption of
HHS. Administration, 10903 New Hampshire certain devices from the application of
ACTION: Notice. Ave., Bldg. 32, Rm. 5103, Silver Spring, portions of the FD&C Act; advises on the
MD 20993–0002. Information about necessity to ban a device; and responds
SUMMARY: The Food and Drug becoming a member of an FDA advisory to requests from the agency to review
Administration (FDA) is requesting that committee can also be obtained by and make recommendations on specific
any industry organizations interested in visiting FDA’s Web site at https:// issues or problems concerning the safety
participating in the selection of www.fda.gov/AdvisoryCommittees/ and effectiveness of devices. With the
nonvoting industry representatives to default.htm. exception of the Medical Devices
serve on certain panels of the Medical Dispute Resolution Panel, each panel,
Devices Advisory Committee (MDAC or FOR FURTHER INFORMATION CONTACT: according to its specialty area, may also
Committee) in the Center for Devices Margaret Ames, Division of Workforce make appropriate recommendations to
and Radiological Health (CDRH) notify Management, Center for Devices and the Commissioner on issues relating to
FDA in writing. FDA is also requesting Radiological Health, Food and Drug the design of clinical studies regarding
nominations for nonvoting industry Administration, 10903 New Hampshire the safety and effectiveness of marketed
representatives to serve on certain Ave., Bldg. 66, Rm. 5264, Silver Spring, and investigational devices. The
device panels of the MDAC in the MD 20993, 301–796–5960, Fax: 301– Committee also provides
CDRH. A nominee may either be self- 847–8505, email: margaret.ames@ recommendations to the Commissioner
nominated or nominated by an fda.hhs.gov. or designee on complexity
organization to serve as a nonvoting SUPPLEMENTARY INFORMATION: The categorization of in vitro diagnostics
industry representative. Nominations Agency is requesting nominations for under the Clinical Laboratory
will be accepted for current and nonvoting industry representatives to Improvement Amendments of 1988.

Panels Function

Circulatory System Devices Panel Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational de-
vices for use in the circulatory and vascular systems and makes appropriate recommendations to the
Commissioner of Food and Drugs.
Clinical Chemistry and Clinical Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in
Toxicology Devices Panel. vitro devices for use in clinical laboratory medicine including clinical toxicology, clinical chemistry, endo-
crinology, and oncology and makes appropriate recommendations to the Commissioner of Food and
Drugs.
Gastroenterology and Urology De- Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gas-
vices Panel. troenterology, urology, and nephrology devices and makes appropriate recommendations to the Com-
missioner of Food and Drugs.
General Hospital and Personal Use Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gen-
Devices Panel. eral hospital, infection control, and personal use devices and makes appropriate recommendations to the
Commissioner of Food and Drugs.
Obstetrics and Gynecology Devices Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational de-
Panel. vices for use in obstetrics and gynecology and makes appropriate recommendations to the Commis-
sioner of Food and Drugs.

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Document Created: 2017-09-28 01:32:44
Document Modified: 2017-09-28 01:32:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		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 October 30, 2017 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by October 30, 2017.
Contact		Margaret Ames, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: [email protected]
FR Citation		82 FR 45298

82 FR 45298 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 187 (September 28, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration