|Device Good Manufacturing Practice Advisory Committee
|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 regarding the feasibility and reasonableness of those proposed regulations. The Committee also advised the Commissioner with regard to any petition submitted by a manufacturer for an exemption or variance from good manufacturing practice regulations that is referred to the committee.
|Experts needed to provide cross-cutting scientific or clinical expertise concerning the particular issue in dispute.
|National Mammography Quality Assurance Advisory Committee
|Advise the agency on the following development of appropriate quality standards and regulations for mammography facilities; standards and regulations for bodies accrediting mammography facilities under this program; regulations with respect to sanctions; procedures for monitoring compliance with standards; establishing a mechanism to investigate consumer complaints; reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities. As well as determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and determining the costs and benefits of compliance with these requirements.
|Physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.
|Patient Engagement Advisory Committee
|Advise the agency, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The Committee may consider topics such as: Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device-related quality of life or health status issues, and other patient-related topics. The Committee will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It will perform its duties by discussing and providing advice and recommendation in ways such as: Identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy.
|Experts who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States. Selected Committee members may also be experienced in the work of patient and health professional organizations; methodologies for eliciting patient preferences; and strategies for communicating benefits, risks and clinical outcomes to patients and research subjects.
|Technical Electronic Product Radiation Standards Advisory Committee
|Reviews and evaluates the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products, and may recommend electronic product radiation safety standards.
|Technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation safety.
|Medical Devices Advisory Committee; Consists of 18 Panels
Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area; advises on the classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; and 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 of Food and Drugs 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 the 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.
|Please refer to panels 1- 18 below for specific information regarding desired expertise.
|1. 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, pharmacology, physiology, or the effects and complications of anesthesia.
|2. 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.
|3. Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
|Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology.
|4. Dental Products Devices Panel of the Medical Devices Advisory Committee
|Dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and dental anatomy.
|5. Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee
|Otologists, neurotologists, audiologists
|6. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
|Gastroenterologists, urologists and nephrologists
|7. General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
|Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians.
|8. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
|Internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, biomedical engineers or microbiologists/infection control practitioners or experts.
|9. Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee
|Hematologists (benign and/or malignant hematology), hematopathologists (general and special hematology, coagulation and homeostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive.
|10. Immunology Devices Panel of the Medical Devices Advisory Committee
|Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
|11. Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee
|Experts with broad, cross-cutting scientific, clinical, analytical or mediation skills.
|12. Microbiology Devices Panel of the Medical Devices Advisory Committee
|Clinicians with an expertise in infectious disease, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists.
|13. Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
|Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The agency is also interested in considering candidates with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training. Additionally, individuals with experience in genetic counseling, medical ethics as well as ancillary fields of study will be considered.
|14. Neurological Devices Panel of the Medical Devices Advisory Committee
|Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, anmovement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.
|15. 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.
|16. 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.
|17. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
|Orthopedic surgeons (joint spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians.
|18. Radiological Devices Panel of the Medical Devices Advisory Committee
|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.
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