Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee, 45773-45776 [2019-18766]
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Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
IV. Paperwork Reduction Act of 1995
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These collections of information are
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45773
of information in the following FDA
regulations and guidance have been
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OMB
control No.
21 CFR part; guidance; or FDA form
Topic
814, subparts A through E .........................................................
814, subpart H ............................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff‘‘.
801 and 809 ...............................................................................
822 ..............................................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ................................................
De Novo classification process ..................................................
0910–0231
0910–0332
0910–0844
Q-submissions ............................................................................
0910–0756
Medical Device Labeling Regulations ........................................
Postmarket Surveillance of Medical Devices .............................
0910–0485
0910–0449
Dated: August 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18802 Filed 8–29–19; 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
SUMMARY:
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 October 29, 2019 will be given
first consideration for membership on
the DGMPAC and Panels of the MDAC.
Nominations received after October 29,
2019 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: 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 COMMITTEE OR PANEL
jspears on DSK3GMQ082PROD 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. 5519, Silver Spring, MD 20993, 301–
796–5421, email: Joannie.Adams-White@fda.hhs.gov.
LCDR Sara Anderson, Office of Management, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993,
301–796–7047, email: Sara.Anderson@fda.hhs.gov.
Aden S. Asefa, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993, 301–796–0400,
email: Aden.Asefa@fda.hhs.gov.
LCDR Patricio G. Garcia, Office of Management, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993,
301–796–6875, email: Patricio.Garcia@fda.hhs.gov.
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Medical Devices Dispute Resolution Panel.
Dental Products Panel, Hematology and Pathology Devices Panel,
Orthopaedic and Rehabilitation Devices Panel, Radiological Devices
Panel.
Immunology Devices Panel, Microbiology Devices Panel, Neurological
Devices Panel, Ophthalmic Devices Panel, DGMPAC.
Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology Devices Panel, General and Plastic Surgery
Devices Panel, Obstetrics and Gynecology Devices Panel.
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Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
TABLE 1—PRIMARY CONTACT AND COMMITTEE OR PANEL—Continued
Primary contact person
Committee or panel
Evella F. Washington, Office of Management, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993 301–
796–6683, email: Evella.Washington@fda.hhs.gov.
Anesthesiology and Respiratory Therapy Devices Panel, Circulatory
System Devices Panel, General Hospital and Personal Use Devices
Panel, Molecular and Clinical Genetics 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
jspears on DSK3GMQ082PROD with NOTICES
Expertise needed
Vacancies
DGMPAC—Experts in medical device quality management system requirements/current Good Manufacturing Practices, with experience in both 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 a representative of the interests of the general public, government, and representatives
of the interests of physicians and other health professionals.
Anesthesiology and Respiratory Therapy Devices Panel of the MDAC—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 MDAC—Interventional cardiologists,
electrophysiologists, invasive (vascular) radiologists, vascular and
cardiothoracic surgeons, and cardiologists with special interest in congestive heart failure.
Clinical Chemistry and Clinical Toxicology Panel of the MDAC—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 MDAC—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.
Gastroenterology and Urology Devices Panel of the MDAC—Gastroenterologists, urologists, and nephrologists.
General and Plastic Surgery Devices Panel of the MDAC—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 of the MDAC—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 MDAC—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 MDAC—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 MDAC—experts with
cross-cutting scientific, clinical, analytical or mediation skills.
Microbiology Devices Panel of the MDAC—Infectious disease (ID) clinicians
(e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric ID specialists, tropical diseases specialists) and clinical
microbiologists experienced in emerging IDs; 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.
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General Public Representative.
Health Professional Representatives.
Government Representative.
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12/1/2019.
1
Immediately.
1
1
Immediately.
3/1/2020.
1
1
Immediately.
11/1/2019.
2
1/1/2020.
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1
1/1/2020.
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3/1/2020.
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3/1/2020.
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10/1/2020.
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3/1/2020.
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Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
45775
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued
Expertise needed
Vacancies
Molecular and Clinical Genetics Panel of the MDAC—Experts in human genetics, molecular diagnostics, and in the clinical management of patients
with genetic disorders, 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 and medical ethics are also desired, and individuals with experience
in ancillary fields of study will be considered.
Neurological Devices Panel of the MDAC—Neurosurgeons (cerebrovascular
and pediatric), neurologists (stroke, pediatric, pain management, and
movement disorders), interventional neuroradiologists, psychiatrists, and
biostatisticians.
Obstetrics and Gynecology Devices Panel of the MDAC—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 MDAC—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 the MDAC—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 MDAC—Physicians with 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.
I. General Description of the
Committees’ Duties
jspears on DSK3GMQ082PROD with NOTICES
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. MDAC
The MDAC reviews and evaluates
data on the safety and effectiveness of
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1
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6/1/2020.
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2
Immediately.
12/1/2019.
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Immediately.
2/1/2020.
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Immediately.
2
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9/1/2020.
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2/1/2020.
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
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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.
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Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
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
jspears on DSK3GMQ082PROD with NOTICES
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 21 CFR 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. 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
Employees. A maximum of 122
members shall be standing voting
members and 37 shall be nonvoting
members who serve as representatives
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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 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 committee(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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18766 Filed 8–29–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–E–0189]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MACI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for MACI and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 29, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 26, 2020. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 29,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 29, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
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
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]]>Agencies
[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45773-45776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18766]
-----------------------------------------------------------------------
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 October 29, 2019 will be given
first consideration for membership on the DGMPAC and Panels of the
MDAC. Nominations received after October 29, 2019 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:
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 Committee or 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. 5519, Silver
Spring, MD 20993, 301-796-5421, email:
[email protected].
LCDR Sara Anderson, Office of Dental Products Panel,
Management, Center for Devices and Hematology and Pathology
Radiological Health, Food and Drug Devices Panel, Orthopaedic and
Administration, 10903 New Hampshire Rehabilitation Devices Panel,
Ave., Bldg. 66, Rm. G616, Silver Radiological Devices Panel.
Spring, MD 20993, 301-796-7047, email:
[email protected].
Aden S. Asefa, Office of Management, Immunology Devices Panel,
Center for Devices and Radiological Microbiology Devices Panel,
Health, Food and Drug Administration, Neurological Devices Panel,
10903 New Hampshire Ave., Bldg. 66, Ophthalmic Devices Panel,
Rm. G642, Silver Spring, MD 20993, 301- DGMPAC.
796-0400, email:
[email protected].
LCDR Patricio G. Garcia, Office of Clinical Chemistry and Clinical
Management, Center for Devices and Toxicology Devices Panel,
Radiological Health, Food and Drug Gastroenterology and Urology
Administration, 10903 New Hampshire Devices Panel, General and
Ave., Bldg. 66, Rm. G610, Silver Plastic Surgery Devices Panel,
Spring, MD 20993, 301-796-6875, email: Obstetrics and Gynecology
[email protected]. Devices Panel.
[[Page 45774]]
Evella F. Washington, Office of Anesthesiology and Respiratory
Management, Center for Devices and Therapy Devices Panel,
Radiological Health, Food and Drug Circulatory System Devices
Administration, 10903 New Hampshire Panel, General Hospital and
Ave., Bldg. 66, Rm. G640, Silver Personal Use Devices Panel,
Spring, MD 20993 301-796-6683, email: Molecular and Clinical
[email protected]. Genetics Panel.
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:
Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
------------------------------------------------------------------------
Approximate date
Expertise needed Vacancies needed
------------------------------------------------------------------------
DGMPAC--Experts in medical device 4 Immediately.
quality management system 1 General Public
requirements/current Good 2 Representative.
Manufacturing Practices, with 1 Health Professional
experience in both 21 CFR part 820 Representatives.
and International Organization for Government
Standardization (ISO) 13485, are Representative.
needed to provide cross-cutting
scientific or clinical expertise
concerning the particular issue in
dispute. Vacancies include a
representative of the interests of
the general public, government,
and representatives of the
interests of physicians and other
health professionals.
Anesthesiology and Respiratory 1 12/1/2019.
Therapy Devices Panel of the MDAC--
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 1 Immediately.
the MDAC--Interventional
cardiologists,
electrophysiologists, invasive
(vascular) radiologists, vascular
and cardiothoracic surgeons, and
cardiologists with special
interest in congestive heart
failure.
Clinical Chemistry and Clinical 1 Immediately.
Toxicology Panel of the MDAC-- 1 3/1/2020.
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 MDAC-- 1 Immediately.
Dentists, engineers, and 1 11/1/2019.
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.
Gastroenterology and Urology 2 1/1/2020.
Devices Panel of the MDAC--
Gastroenterologists, urologists,
and nephrologists.
General and Plastic Surgery Devices 4 Immediately.
Panel of the MDAC--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 1 1/1/2020.
Devices Panel of the MDAC--
Internists, pediatricians,
neonatologists, endocrinologists,
gerontologists, nurses, biomedical
engineers, human factors experts,
or microbiologists/infection
control practitioners or experts.
Hematology and Pathology Devices 2 3/1/2020.
Panel of the MDAC--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 3 Immediately.
MDAC--Persons with experience in 2 3/1/2020.
medical, surgical, or clinical
oncology, internal medicine,
clinical immunology, allergy,
molecular diagnostics, or clinical
laboratory medicine.
Medical Devices Dispute Resolution 1 10/1/2020.
Panel of the MDAC--experts with
cross-cutting scientific,
clinical, analytical or mediation
skills.
Microbiology Devices Panel of the 2 3/1/2020.
MDAC--Infectious disease (ID)
clinicians (e.g., pulmonary
disease specialists, sexually
transmitted disease specialists,
pediatric ID specialists, tropical
diseases specialists) and clinical
microbiologists experienced in
emerging IDs; 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.
[[Page 45775]]
Molecular and Clinical Genetics 2 Immediately.
Panel of the MDAC--Experts in 1 6/1/2020.
human genetics, molecular
diagnostics, and in the clinical
management of patients with
genetic disorders, 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 and medical
ethics are also desired, and
individuals with experience in
ancillary fields of study will be
considered.
Neurological Devices Panel of the 1 Immediately.
MDAC--Neurosurgeons 2 12/1/2019.
(cerebrovascular and pediatric),
neurologists (stroke, pediatric,
pain management, and movement
disorders), interventional
neuroradiologists, psychiatrists,
and biostatisticians.
Obstetrics and Gynecology Devices 2 Immediately.
Panel of the MDAC--Experts in 1 2/1/2020.
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 3 Immediately.
MDAC--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 2 Immediately.
Devices Panel of the MDAC-- 2 9/1/2020.
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 1 2/1/2020.
MDAC--Physicians with 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.
------------------------------------------------------------------------
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. 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.
[[Page 45776]]
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 21 CFR 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. 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 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 Non-Voting 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 committee(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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18766 Filed 8-29-19; 8:45 am]
BILLING CODE 4164-01-P
