The FDA is requesting nominations for members and consultants to serve as advisors on the Medical
Devices Advisory Committee. FDA encourages qualified female, minority, and physically
disabled candidates to apply.
FUNCTION OF THE COMMITTEE
The Committee consists of 18 panels. Panel members are asked to provide their expert scientific and technical advice to the Center to help make sound decisions on the classification/reclassification as well as the safety, effectiveness, and appropriate use of medical products.
Persons nominated must be experts in their field (e.g., clinical medicine, engineering, biological and physical sciences, and biostatistics) and have experience in medical practice, teaching, and/or relevant research. The Agency will make its selections based on the expertise required to meet its specific needs. Every effort will be made to ensure appropriate balance of membership. Potential candidates will be asked to provide detailed information concerning financial holdings, employment, and research grants and contracts to identify any potential conflict of interest.
ADDITIONAL EXPERTISE NEEDED
Anesthesiology and Respiratory Therapy Devices Panel: anesthesiologists, pulmonary medicine specialists, or other experts who have relevant specialized interests in ventilatory support, pharmacology, physiology, or the effects and complications of anesthesia, and who have general expertise in the evaluation of clinical data.
Circulatory System Devices Panel: interventional cardiologists, interventional radiologists, vascular and cardiothoracic surgeons, or cardiologists, especially those with special interest in vascular effects of radiation and congestive heart failure.
Clinical Chemistry and Clinical Toxicology Devices Panel: doctors of medicine or philosophy with experience in clinical chemistry, clinical toxicology, clinical pathology, clinical laboratory medicine, endocrinology, or oncology.
Dental Products Panel: dentists who have experience with lasers, endosseous implants, temporomandibular joint implants or endodontics, in addition to experts in bone physiology relative to the oral and maxillofacial area or tissue engineering in oral applications.
Dispute Resolution Panel: experts with cross-cutting scientific, clinical, analytical or mediation skills.
Ear, Nose and Throat Devices Panel: otolaryngologists, biomedical or electrical engineers, electrophysiologists, neurophysiologists, audiologists, or statisticians.
Gastroenterology and Urology Devices Panel: nephrologists, urologists, or gastroenterologists with expertise in diagnostic and therapeutic management of adult and pediatric patient populations.
General and Plastic Surgery Devices Panel: general surgeons, plastic surgeons, and experts in biomaterials, lasers, wound healing, or endoscopic surgery, and tissue engineering.
General Hospital and Personal Use Devices Panel: internists, pediatricians, neonatologists, nurses, gerontologists, biomedical engineers or micro-biologists/infection control practitioners or experts.
Hematology and Pathology Devices Panel: cytopathologists, hematologists (blood banking, coagulation and hemostasis), hematopathologists (oncology), histopathologists, molecular biologists (nucleic acid amplification techniques) or cytotechnologists.
Immunology Devices Panel: persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, or clinical laboratory medicine. Areas of expertise include: tumor markers, allergic diseases, autoimmune diseases, flow cytometry, oncogenes, and molecular diagnostics.
Microbiology Devices Panel: infectious disease 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: experts in human genetics and clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, and neonatalogists: biochemical and/or molecular genetics, molecular diagnostics, inborn errors of metabolism, population genetics, epidemiology, genetic counseling, and medical ethics.
Neurological Devices Panel: neurologists, epileptologists, interventional neuroradiologists, neurosurgeons, biomaterials experts, biomedical engineers, or persons experienced with neurological devices with a strong background in biostatistics.
Obstetrics and Gynecology Devices Panel: experts in surgical treatment of abnormal uterine bleeding, contraception, urogynecology, reproductive endocrinology, or endoscopy.
Ophthalmic Devices Panel: ophthalmologists specializing in refractive surgery and vitreo-retinal surgery; and the treatment of glaucoma, in addition to vision scientists and electrophysiologists.
Orthopaedic and Rehabilitation Devices Panel: orthopedic surgeons experienced with prosthetic ligament devices, joint implants, or spinal instrumentation; physical therapists experienced in spinal cord injuries, neurophysiology, electrotherapy, or joint biomechanics; rheumatologists; biomedical engineers; or experience in tissue engineering, calcification or biomaterials.
Radiological Devices Panel: physicians and scientists with expertise in nuclear medicine, diagnostic or therapeutic radiology, radiation oncology with special interest in vascular effects of radiation, mammography, thermography, transillumination, hyperthermia cancer therapy, bone densitometry, magnetic resonance imaging, computed tomography, ultrasound, statistical analysis or digital image processing.
1-4 meetings per year.
Washington, D.C. area - usually in Rockville or Gaithersburg, Maryland.
SALARY AND TRAVEL EXPENSES
Advisors are appointed as Special Government Employees and receive a salary for each meeting day as well as travel and per diem costs.
WHAT TO SEND
A letter of self-nomination, or a letter of nomination from a peer or professional organization or society, with a current curriculum vitae and bibliography. Nominations should include the following statements:
- the nominee is willing to serve,
- the nominee is qualified; and
- the nominee appears to have no conflict of interest that would adversely affect the integrity of our regulatory process.
WHERE TO SEND NOMINATIONS
James Paul Swink
Acting Director, Advisory Panel Program
Medical Devices Advisory Committee
Center for Devices and Radiological Health
10903 New Hampshire Ave.
Bldg. 66 Rm. 1609
Silver Spring, MD, 20993
Nominations will be accepted on a continuing basis. Selections will be determined by the expertise needed to fill an existing or anticipated vacancy.
Revised 8/95, 9/99, 2/06, 7/06, 4/07