
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8207-8208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


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) 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) 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. 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.

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 FDA by March 21, 
2016, (see sections I and II for further details). Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by March 21, 2016.

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 may 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 
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993, 301-796-5960, Fax: 
301-847-8505, margaret.ames@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for 
nonvoting industry representatives to certain panels identified in the 
following paragraphs:

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 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 
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 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 of Food and Drugs 
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.

A. Anesthesiology and Respiratory Therapy Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational devices for use in anesthesiology and 
respiratory therapy and makes appropriate recommendations to the 
Commissioner of Food and Drugs.

B. Ear, Nose and Throat Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational ear, nose and throat devices and makes 
appropriate recommendations to the Commissioner of Food and Drugs.

[[Page 8208]]

C. Gastroenterology and Urology Devices Panel

    Reviews and evaluates data 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.

D. General and Plastic Surgery Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational general and plastic surgery devices and 
makes appropriate recommendations to the Commissioner of Food and 
Drugs.

E. Hematology and Pathology Devices Panel

    Reviews and evaluates data concerning 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 of Food and Drugs.

F. Medical Devices Dispute Resolution

    Provides advice to the Center Director on complex or contested 
scientific issues between the FDA and medical device sponsors, 
applicants, or manufacturers relating to specific products, marketing 
applications, regulatory decisions and actions by FDA, and Agency 
guidance and policies. The Panel makes recommendations on issues that 
are lacking resolution, are highly complex in nature, or result from 
challenges to Agency decisions or actions.

G. Microbiology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational in vitro devices for use in clinical 
laboratory medicine including microbiology, virology, and infectious 
disease and makes appropriate recommendations to the Commissioner of 
Food and Drugs.

H. Molecular and Clinical Genetics Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational in vitro devices for use in clinical 
laboratory medicine including clinical and molecular genetics and makes 
appropriate recommendations to the Commissioner of Food and Drugs.

I. Neurological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational devices for use in the neurological 
system and makes appropriate recommendations to the Commissioner of 
Food and Drugs.

J. Orthopaedic and Rehabilitation Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational orthopedic and rehabilitation devices 
and makes appropriate recommendations to the Commissioner of Food and 
Drugs.

K. Radiological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational diagnostics 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 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 Committee of interest may be submitted 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 panel. 
(Persons who nominate themselves as nonvoting industry representatives 
will not participate in the selection process).
    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: February 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03283 Filed 2-17-16; 8:45 am]
 BILLING CODE 4164-01-P


