[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71643-71646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
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:

[[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,
 [email protected].
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, [email protected].
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,
 [email protected].
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,
 [email protected].              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.
 [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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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