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

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Published

December 17, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. 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.

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<title>Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)</title>
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[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71643-71646]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27376]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3926]

Request for Nominations for Voting Members 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
nominations for voting members to serve on the Medical Devices Advisory
Committee (MDAC) device panels in the Center for Devices and
Radiological Health. This annual notice is also in accordance with the
21st Century Cures Act, which requires the Secretary of Health and
Human Services (the Secretary) to provide an annual opportunity for
patients, representatives of patients, and sponsors of medical devices
that may be specifically the subject of a review by a classification
panel to provide recommendations for individuals with appropriate
expertise to fill voting member positions on classification panels. 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: Nominations received on or before February 15, 2022, will be
given first consideration for membership on the Panels of the MDAC.
Nominations received after February 15, 2022, will be considered for
nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal at
<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 on 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: Regarding all nomination questions for
membership, contact the following persons listed in table 1:

[[Page 71644]]

Table 1--Primary Contact and Committee or Panel
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Primary contact person Committee or panel
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Joannie Adams-White, Office of the Medical Devices Dispute
Center Director, Center for Devices Resolution Panel.
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5561, Silver
Spring, MD 20993, 301-796-5421,
<a href="/cdn-cgi/l/email-protection#bcf6d3ddd2d2d5d992fdd8ddd1cf91ebd4d5c8d9fcdad8dd92d4d4cf92dbd3ca">[email&#160;protected]</a>.
James P. Swink, Office of Management, Circulatory System Devices
Center for Devices and Radiological Panel, Immunology Devices
Health, Food and Drug Administration, Panel, Microbiology Devices
10903 New Hampshire Ave., Bldg. 66 Rm. Panel,Ophthalmic Devices
5211, Silver Spring, MD 20993, 301-796- Panel.
6313, <a href="/cdn-cgi/l/email-protection#e2a8838f8791ccb1958b8c89a2848683cc8a8a91cc858d94">[email&#160;protected]</a>.
Akinola Awojope, Office of Management, Dental Products Panel,
Center for Devices and Radiological Neurological Devices Panel,
Health, Food and Drug Obstetrics and Gynecology
Administration,10903 New Hampshire Devices Panel Orthopaedic and
Ave., Bldg. 66, Rm. 5216, Silver Rehabilitation Devices Panel.
Spring, MD 20993, 301-636-0512,
<a href="/cdn-cgi/l/email-protection#d899b3b1b6b7b4b9f699afb7b2b7a8bd98bebcb9f6b0b0abf6bfb7ae">[email&#160;protected]</a>.
Jarrod Collier, Office of Management, Ear, Nose and Throat Devices
Center for Devices and Radiological Panel, General Hospital and
Health, Food and Drug Personal Use Devices Panel,
Administration,10903 New Hampshire Hematology and Pathology
Ave., Bldg. 66, Rm. 5216, Silver Devices Panel, Molecular and
Spring, MD 20993, 301-796-6875, Clinical Genetics Panel,
<a href="/cdn-cgi/l/email-protection#5812392a2a373c761b373434313d2a183e3c397630302b763f372e">[email&#160;protected]</a>. Radiological Devices Panel.
Candace Nalls, Office of Management, Anesthesiology and Respiratory
Center for Devices and Radiological Therapy Devices Panel,
Health, Food and Drug Clinical Chemistry and
Administration,10903 New Hampshire Clinical Toxicology Devices
Ave., Bldg. 66, Rm. 5214, Silver Panel, General and Plastic
Spring, MD 20993, 301-636-0510, Surgery Devices Panel.
<a href="/cdn-cgi/l/email-protection#4c0f2d22282d2f2962022d20203f0c2a282d6224243f622b233a">[email&#160;protected]</a>.
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SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:

Table 2-- Expertise Needed, Vacancies, and Approximate Date Needed
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Expertise needed Vacancies Approximate date needed
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Anesthesiology and Respiratory Therapy Devices 3 Immediately.
Panel of the Medical Devices Advisory
Committee--Anesthesiologists, pulmonary
medicine specialists, or other experts who
have specialized interests in ventilator
support, sleep medicine, pharmacology,
physiology, or the effects and complications
of anesthesia. FDA is also seeking applicants
with pediatric expertise in these areas.
Circulatory System Devices Panel of the Medical 1 Immediately.
Devices Advisory Committee--Interventional 1 July 1, 2022.
cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and
cardiothoracic surgeons, and cardiologists
with special interest in congestive heart
failure.
Clinical Chemistry and Clinical Toxicology 1 March 1, 2022.
Panel of the Medical Devices Advisory
Committee--Doctors of medicine or philosophy
with experience in clinical chemistry (e.g.,
cardiac markers), clinical toxicology,
clinical pathology, clinical laboratory
medicine, and endocrinology.
Dental Products Panel of the Medical Devices 3 Immediately.
Advisory Committee--Dentists, engineers, and
scientists who have expertise in the areas of
dental implants, dental materials, oral and
maxillofacial surgery, endodontics,
periodontology, tissue engineering, snoring/
sleep therapy, and dental anatomy.
Ear, Nose, and Throat Devices Panel of the 4 Immediately.
Medical Devices Advisory Committee--
Otologists, neurotologists, and audiologists.
General and Plastic Surgery Devices Panel of 4 Immediately.
the Medical Devices Advisory Committee--
Surgeons (general, plastic, reconstructive,
pediatric, thoracic, abdominal, pelvic, and
endoscopic); dermatologists; experts in
biomaterials, lasers, wound healing, and
quality of life; and biostatisticians.
General Hospital and Personal Use Devices Panel 2 Immediately.
of the Medical Devices Advisory Committee-- 1 January 1, 2022.
Internists, pediatricians, neonatologists,
endocrinologists, gerontologists, nurses,
biomedical engineers, human factors experts,
or microbiologists/infection control
practitioners or experts.
Hematology and Pathology Devices Panel of the 3 Immediately.
Medical Devices Advisory Committee-- 1 March 1, 2022.
Hematologists (benign and/or malignant
hematology), hematopathologists (general and
special hematology, coagulation and
hemostasis, and hematological oncology),
gynecologists with special interests in
gynecological oncology, cytopathologists, and
molecular pathologists with special interests
in development of predictive and prognostic
biomarkers, molecular oncology, cancer
screening, cancer risk, digital pathology,
whole slide imaging; devices utilizing
artificial intelligence/machine learning.
Immunology Devices Panel of the Medical Devices 7 Immediately.
Advisory Committee--Persons with experience in
medical, surgical, or clinical oncology,
internal medicine, clinical immunology,
allergy, molecular diagnostics, or clinical
laboratory medicine.
Medical Devices Dispute Resolution Panel of the 1 October 1, 2022.
Medical Devices Advisory Committee--Experts
with cross-cutting scientific, clinical,
analytical or mediation skills.

[[Page 71645]]

Microbiology Devices Panel of the Medical 5 Immediately.
Devices Advisory Committee--Infectious disease 2 March 1, 2022.
clinicians (e.g., pulmonary disease
specialists, sexually transmitted disease
specialists, pediatric ID specialists,
tropical diseases specialists) and clinical
microbiologists experienced in emerging
infectious diseases; clinical microbiology
laboratory directors; molecular biologists
with experience in in vitro diagnostic device
testing; virologists; hepatologists; or
clinical oncologists experienced with tumor
resistance and susceptibility.
Molecular and Clinical Genetics Panel of the 2 Immediately.
Medical Devices Advisory Committee--Experts in 2 June 1, 2022.
human genetics, molecular diagnostics, and in
the clinical management of patients with
genetic disorders, and (e.g., pediatricians,
obstetricians, neonatologists). Individuals
with training in inborn errors of metabolism,
biochemical and/or molecular genetics,
population genetics, epidemiology and related
statistical training, bioinformatics,
computational genetics/genomics, variant
classification, cancer genetics/genomics,
molecular oncology, radiation biology, and
clinical molecular genetics testing, (e.g.,
sequencing, whole exome sequencing, whole
genome sequencing, non-invasive prenatal
testing, cancer screening, circulating cell
free/circulating tumor nucleic acid testing,
digital PCR, genotyping, array CGH, etc.).
Individuals with experience in genetics
counseling, medical ethics are also desired,
and individuals with experience in ancillary
fields of study will be considered.
Neurological Devices Panel of the Medical 2 Immediately.
Devices Advisory Committee--Neurosurgeons
(cerebrovascular and pediatric), neurologists
(stroke, pediatric, pain management, and
movement disorders), interventional
neuroradiologists, psychiatrists, and
biostatisticians.
Obstetrics and Gynecology Devices Panel of the 4 Immediately.
Medical Devices Advisory Committee--Experts in 1 February 1, 2022.
perinatology, embryology, reproductive
endocrinology, pediatric gynecology,
gynecological oncology, operative
hysteroscopy, pelviscopy, electrosurgery,
laser surgery, assisted reproductive
technologies, contraception, postoperative
adhesions, and cervical cancer and colposcopy;
biostatisticians and engineers with experience
in obstetrics/gynecology devices;
urogynecologists; experts in breast care;
experts in gynecology in the older patient;
experts in diagnostic (optical) spectroscopy;
experts in midwifery; labor and delivery
nursing.
Ophthalmic Devices Panel of the Medical Devices 4 Immediately.
Advisory Committee--Ophthalmologists
specializing in cataract and refractive
surgery and vitreo-retinal surgery, in
addition to vision scientists, optometrists,
and biostatisticians practiced in ophthalmic
clinical trials.
Orthopaedic and Rehabilitation Devices Panel of 2 Immediately.
the Medical Devices Advisory Committee-- 2 September 1, 2022.
Orthopaedic surgeons (joint, spine, trauma,
reconstruction, sports medicine, hand, foot
and ankle, and pediatric orthopaedic
surgeons); rheumatologists; engineers
(biomedical, biomaterials, and biomechanical);
experts in rehabilitation medicine, and
musculoskeletal engineering; radiologists
specializing musculoskeletal imaging and
analyses and biostatisticians.
Radiological Devices Panel of the Medical 3 Immediately.
Devices Advisory Committee--Physicians with 4 February 1, 2022.
experience in general radiology, mammography,
ultrasound, magnetic resonance, computed
tomography, other radiological subspecialties
and radiation oncology; scientists with
experience in diagnostic devices, radiation
physics, statistical analysis, digital imaging
and image analysis.
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I. General Description of the Committee Duties

The MDAC reviews and evaluates data on the safety and effectiveness
of marketed and investigational devices and makes recommendations for
their regulation. The panels engage in many 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,
performs the following duties: (1) Advises the Commissioner regarding
recommended classification or reclassification of devices into one of
three regulatory categories, (2) advises on any possible risks to
health associated with the use of devices, (3) advises on formulation
of product development protocols, (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the FD&C Act, (7) advises on the necessity
to ban a device, and (8) 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 Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between 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 regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Voting Members

The MDAC with its 18 panels shall consist of a maximum of 159
standing members. Members are selected by the Commissioner or designee
from among authorities in clinical and administrative medicine,
engineering, biological and physical sciences, and other related
professions. Almost all non-Federal members of this committee serve as
Special Government Employees. A maximum of 122 members shall be
standing voting

[[Page 71646]]

members and 37 shall be nonvoting members who serve as representatives
of consumer interests and of industry interests. FDA is publishing
separate documents announcing the Request for Nominations Notification
for Nonvoting Representatives on certain panels of the MDAC. Persons
nominated for membership on the panels should have adequately
diversified experience appropriate to the work of the panel in such
fields as clinical and administrative medicine, engineering, biological
and physical sciences, statistics, and other related professions. The
nature of specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment may include experience in
medical practice, teaching, and/or research relevant to the field of
activity of the panel. The current needs for each panel are listed in
table 2. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

Any interested person may nominate one or more qualified
individuals for membership on one or more of the advisory panels. Self-
nominations are also accepted. Nominations must include a current,
complete r[eacute]sum[eacute] or curriculum vitae for each nominee,
including current business address, telephone number, and email address
if available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must also specify the advisory panel(s) for which the
nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will ask
potential candidates to provide detailed information concerning such
matters related to financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflict
of interest.
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 13, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27376 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P

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