[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80307-80310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25367]
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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 or Committees; Device Good Manufacturing Practice Advisory
Committee and 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 Device Good
Manufacturing Practice Advisory Committee (DGMPAC) and 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 January 16, 2024, will be
given first consideration for membership on the DGMPAC and Panels of
the MDAC. Nominations received after January 16, 2024, 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
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 on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:
Table 1--Primary Contact and 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,
[email protected].
James P. Swink, Office of Management, Circulatory System Devices
Center for Devices and Radiological Panel, Ophthalmic Devices
Health, Food and Drug Administration, Panel.
10903 New Hampshire Ave., Bldg. 66,
Rm. 5211, Silver Spring, MD 20993, 301-
796-6313, [email protected].
Akinola Awojope, Office of Management, Dental Products Panel,
Center for Devices and Radiological Neurological Devices Panel,
Health, Food and Drug Administration, Obstetrics and Gynecology
10903 New Hampshire Ave., Bldg. 66, Devices Panel, Orthopaedic and
Rm. 5216, Silver Spring, MD 20993, 301- Rehabilitation Devices Panel.
636-0512, [email protected].
[[Page 80308]]
Jarrod Collier, Office of Management, DGMPAC, General Hospital and
Center for Devices and Radiological Personal Use Devices Panel,
Health, Food and Drug Administration, Hematology and Pathology
10903 New Hampshire Ave., Bldg. 66, Devices Panel, Molecular and
Rm. 5216, Silver Spring, MD 20993, 240- Clinical Genetics Panel.
672-5763, [email protected].
Candace Nalls, Office of Management, Anesthesiology and Respiratory
Center for Devices and Radiological Therapy Devices Panel; Ear,
Health, Food and Drug Administration, Nose, and Throat Devices
10903 New Hampshire Ave., Bldg. 66, Panel; Gastroenterology and
Rm. 5214, Silver Spring, MD 20993, 301- Urology Devices Panel.
636-0510, [email protected].
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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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Device Good Manufacturing Practice Advisory 1 Immediately.
Committee--Experts in medical device quality 2 June 1, 2024.
management system requirements/current good
manufacturing practices, with experience in
both part 820 (21 CFR part 820) and
International Organization for
Standardization (ISO) 13485, are needed to
provide cross-cutting scientific or clinical
expertise concerning the particular issue in
dispute. Vacancies include representatives
of the interests of the general public and
government.
Anesthesiology and Respiratory Therapy 1 December 1, 2024.
Devices 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 3 July 1, 2024.
Medical Devices Advisory Committee--
Interventional cardiologists,
electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic
surgeons, and cardiologists with special
interest in congestive heart failure.
Dental Products Panel of the Medical Devices 7 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 7 Immediately.
Medical Devices Advisory Committee--
Otologists, neurotologists, and audiologists.
Gastroenterology and Urology Devices Panel of 2 January 1, 2024.
the Medical Devices Advisory Committee--
Gastroenterologists, urologists, and
nephrologists.
General Hospital and Personal Use Devices 1 Immediately.
Panel of the Medical Devices Advisory 2 January 1, 2024.
Committee--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 4 Immediately.
Medical Devices Advisory Committee--
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.
Medical Devices Dispute Resolution Panel of 1 Immediately.
the Medical Devices Advisory Committee-- 1 October 1, 2024.
Experts with cross-cutting scientific,
clinical, analytical or mediation skills.
Molecular and Clinical Genetics Panel of the 2 Immediately.
Medical Devices Advisory Committee--Experts
in 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 polymerase chain reaction,
genotyping, array comparative genomic
hybridization, 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 2 December 1, 2023.
(cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians.
[[Page 80309]]
Obstetrics and Gynecology Devices Panel of 2 February 1, 2024.
the Medical Devices Advisory Committee--
Experts in 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 3 November 1, 2024.
Devices Advisory Committee--Ophthalmologists
with expertise in corneal-external disease,
vitreo-retinal surgery, glaucoma, ocular
immunology, ocular pathology; optometrists;
vision scientists; and ophthalmic
professionals with expertise in clinical
trial design, quality of life assessment,
electrophysiology, low vision
rehabilitation, and biostatistics.
Orthopaedic and Rehabilitation Devices Panel 1 Immediately.
of the Medical Devices Advisory Committee-- 2 September 1, 2024.
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 in musculoskeletal
imaging and analyses and biostatisticians.
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I. General Description of the Committees Duties
A. DGMPAC
The DGMPAC reviews regulations proposed for promulgation regarding
good manufacturing practices governing the methods used in, and the
facilities and controls used for, the manufacture, packing, storage and
installation of devices, and makes recommendations to the Commissioner
of Food and Drugs (the Commissioner) regarding the feasibility and
reasonableness of those proposed regulations. The DGMPAC also advises
the Commissioner on any petition submitted by a manufacturer for an
exemption or variance from good manufacturing practice regulations that
is referred to the committee.
B. Panels of MDAC
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
A. DGMPAC
The DGMPAC consists of a core of nine members including the Chair.
Members and the Chair are selected by the Secretary. Persons nominated
for membership as a health professional or officer or employee of any
Federal, State, or local government should have knowledge of or
expertise in any one or more of the following areas: quality assurance
concerning the design, manufacture, and use of medical devices in
accordance with part 820 and/or ISO 13485. To be eligible for selection
as a representative of the general public, nominees should possess
appropriate qualifications to understand and contribute to the DGMPAC's
work. Three of the members shall be officers or employees of any State
or local government or of the Federal Government; two shall be
representative of the interests of the device manufacturing industry;
two shall be representatives of the interests of physicians and other
health professionals; and two shall be representatives of the interests
of the general public. FDA is publishing a separate document announcing
the Request for Nominations Notification for Non-Voting Representatives
of the interests of the device manufacturing industry. Almost all non-
Federal members of this committee serve as Special Government
Employees. Members are invited to serve for overlapping terms of 4
years. The current needs for the DGMPAC are listed in table 2.
B. Panels of the MDAC
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
[[Page 80310]]
Employees. A maximum of 122 members shall be standing voting 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 or
advisory committees. 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 committees or 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: November 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25367 Filed 11-16-23; 8:45 am]
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