Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee, 80307-80310 [2023-25367]
Download as PDF
<![CDATA[
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website and at the location of the
advisory committee meeting, and the
background material will be posted on
FDA’s website after the meeting.
Background material will be available at
https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
January 16, 2024, will be provided to
the Committee. Oral presentations from
the public will be scheduled on
February 6, 2024, between
approximately 1 p.m. and 2 p.m. Eastern
Time. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before January 5, 2024. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by January 8, 2024.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Artair Mallett
at Artair.Mallett@fda.hhs.gov or 301–
796–9638 at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.).
Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–25459 Filed 11–16–23; 8:45 am]
BILLING CODE 4164–01–P
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.
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)
SUMMARY:
80307
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.
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, contact the following
persons listed in table 1:
TABLE 1—PRIMARY CONTACT AND PANEL
khammond on DSKJM1Z7X2PROD with NOTICES
Primary contact person
Committee or panel
Joannie Adams-White, Office of the Center Director, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5561, Silver Spring, MD 20993, 301–
796–5421, Joannie.Adams-White@fda.hhs.gov.
James P. Swink, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993, 301–796–6313,
James.Swink@fda.hhs.gov.
Akinola Awojope, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993, 301–636–
0512, Akinola.Awojope@fda.hhs.gov.
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
PO 00000
Frm 00039
Fmt 4703
Medical Devices Dispute Resolution Panel.
Circulatory System Devices Panel, Ophthalmic Devices Panel.
Dental Products Panel, Neurological Devices Panel, Obstetrics and
Gynecology Devices Panel, Orthopaedic and Rehabilitation Devices
Panel.
Sfmt 4703
E:\FR\FM\17NON1.SGM
17NON1
80308
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
TABLE 1—PRIMARY CONTACT AND PANEL—Continued
Primary contact person
Committee or panel
Jarrod Collier, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993, 240–672–5763,
Jarrod.Collier@fda.hhs.gov.
Candace Nalls, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993, 301–636–0510,
Candace.Nalls@fda.hhs.gov.
DGMPAC, General Hospital and Personal Use Devices Panel, Hematology and Pathology Devices Panel, Molecular and Clinical Genetics
Panel.
Anesthesiology and Respiratory Therapy Devices Panel; Ear, Nose,
and Throat Devices Panel; Gastroenterology and Urology Devices
Panel.
FDA is
requesting nominations for voting
members for vacancies listed in table 2:
SUPPLEMENTARY INFORMATION:
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED
khammond on DSKJM1Z7X2PROD with NOTICES
Expertise needed
Vacancies
Device Good Manufacturing Practice Advisory Committee—Experts in medical device quality
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 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 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 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 Medical Devices Advisory Committee—Otologists,
neurotologists, and audiologists.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—Gastroenterologists, urologists, and nephrologists.
General Hospital and Personal Use Devices Panel of the Medical Devices Advisory 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 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 the Medical Devices Advisory Committee—Experts
with cross-cutting scientific, clinical, analytical or mediation skills.
Molecular and Clinical Genetics Panel of the 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 Devices Advisory Committee—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement
disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
E:\FR\FM\17NON1.SGM
17NON1
Approximate date needed
1
2
Immediately.
June 1, 2024.
1
December 1, 2024.
3
July 1, 2024.
7
Immediately.
7
Immediately.
2
January 1, 2024.
1
2
Immediately.
January 1, 2024.
4
Immediately.
1
1
2
Immediately.
October 1, 2024.
Immediately.
2
2
Immediately.
December 1, 2023.
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
80309
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued
Expertise needed
Vacancies
Obstetrics and Gynecology Devices Panel of 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 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 of the Medical Devices Advisory Committee—
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.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
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-thecounter 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Approximate date needed
2
February 1, 2024.
3
November 1, 2024.
1
2
Immediately.
September 1, 2024.
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
E:\FR\FM\17NON1.SGM
17NON1
80310
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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 re´sume´ 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 selfnominated. 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]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0053]
Notifying the Food and Drug
Administration of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the Federal Food,
Drug, and Cosmetic Act; Final
Guidance for Industry and Food and
Drug Administration Staff; and Select
Updates for the 506J Guidance: 506J
Device List and Additional
Notifications; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the final
guidance entitled ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act’’ and the draft guidance entitled
‘‘Select Updates for the 506J Guidance:
506J Device List and Additional
Notifications.’’ The Federal Food, Drug,
and Cosmetic Act (FD&C Act) requires
manufacturers to notify FDA of a
permanent discontinuance or an
interruption in the manufacture of
certain devices that is likely to lead to
a meaningful disruption in supply of
that device in the United States during
or in advance of a public health
emergency (PHE). This final guidance is
intended to assist manufacturers in
providing timely, informative
notifications about changes in the
production of certain medical device
products that will help prevent or
mitigate shortages of such devices. FDA
is concurrently issuing a draft guidance
to propose select updates to the final
guidance ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act.’’ This draft guidance proposes a list
of device product codes for which a
manufacturer of such devices is
required to notify FDA in accordance
with the FD&C Act (hereafter referred to
as the ‘‘506J Device List’’) and clarifies
that manufacturers may submit
voluntary notifications regarding supply
chain issues at any time, unrelated to
the declaration or potential declaration
of a PHE. This draft guidance is not final
nor is it for implementation at this time.
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the draft guidance
by February 15, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–D–0053 for ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act’’ or ‘‘Select Updates for the 506J
Guidance: 506J Device List and
Additional Notifications.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Primary contact person Committee or panel
------------------------------------------------------------------------
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].
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:
Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Expertise needed Vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
