Help Wanted: CDRH Seeks Experts for 18 Advisory Panels
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday sought nominations for experts to serve as voting members of the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and panels that make up the Medical Devices Advisory Committee (MDAC).For DGMPAC, FDA is seeking 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. Vacancies include a representative of general public interests, government and representatives of the interests of physicians and other health professionals.
The MDAC, meanwhile, includes a series of panels that review and evaluate data on the safety and effectiveness of marketed and investigational devices. Here’s a rundown of a few of the MDAC panels that CDRH is looking to add experts to:
Four experts are needed immediately, FDA said, for the General and Plastic Surgery Devices Panel of the MDAC. Such experts can include surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians.
Five experts are needed for the Immunology Devices Panel of the MDAC. Specifically, the agency wants those with experience in medical, surgical or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics or clinical laboratory medicine.
CDRH is also seeking four experts for its Orthopaedic and Rehabilitation Devices Panel, three experts for its Ophthalmic Devices Panel, three for the Obstetrics and Gynecology Devices Panel, three for the Neurological Devices Panel and three for the Molecular and Clinical Genetics Panel.
CDRH is also seeking an expert for its Medical Devices Dispute Resolution Panel, which makes recommendations on issues that, according to FDA, “are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions.”
Federal Register