Medical Device Advisory Committee: Purpose, Structure, and Functions
The Medical Device Advisory Committee, chaired by Dr. Amit J. Shanker, reviews and evaluates data on the safety and effectiveness of medical devices. With 18 specialty panels and 159 standing members, it advises the FDA Commissioner on regulating devices. Functions include recommending device classification and advising on potential risks.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
FDA Medical Device Advisory Committee Amit J Shanker, MD, FHRS Chair, Cardiovascular Medicine, St Lawrence Health System Vice Chair, HRS Health Policy and Regulatory Affairs Comm Advisor, FDA Medical Device Advisory Committee
Medical Device Advisory Committee Purpose and Structure Purpose: When additional expert counsel is required (beyond FDA s available internal resources) Reviews and evaluation of data on the safety and effectiveness of marketed and investigational devices and making recommendations for their regulation Advising the Commissioner in discharging responsibilities as they relate to assuring safety and effectiveness of medical devices. Structure: 18 panels according to specialty area 159 standing members (122 physician experts/voting authority, 37 consumer/industry members/non-voting) Selected by the Commissioner or designee from authorities
Medical Device Advisory Committee Purpose and Structure 18 Specialty Panels: Circulatory System Anesthesiology and Respiratory Clinical Chemistry and Toxicology Dental Products Ear, Nose, and Throat Gastroenterology and Urology General and Plastic Surgery General Hospital and Personal Use Hematology and Pathology Immunology *Medical Devices Dispute Resolution Microbiology Molecular and Clinical Genetics Neurological Obstetrics and Gynecology Ophthalmic Orthopaedic and Rehabilitation Radiological
Medical Device Advisory Committee Purpose and Structure Purpose: When additional expert counsel is required (beyond FDA s available internal resources) Reviews and evaluation of data on the safety and effectiveness of marketed and investigational devices and making recommendations for their regulation Advising the Commissioner in discharging responsibilities as they relate to assuring safety and effectiveness of medical devices. Structure: 18 panels according to specialty area 159 standing members (122 physician experts/voting authority, 37 consumer/industry members/non-voting) Selected by the Commissioner or designee from authorities
Medical Device Advisory Committee Functions Recommend classification or reclassification of devices into one of three regulatory categories Advise on any possible risks to health associated with the use of devices Advise on formulation of product development protocols Review premarket approval applications for medical devices Review guidelines and guidance documents Recommend exemption of certain devices from the application of portions of the Act Advise on the necessity to ban a device Respond to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices Recommend on issues relating to the design of clinical studies regarding the safety and effectiveness
Medical Device Advisory Committee Recent Guidance 2016: Heater-Cooler Devices, Amplatzer PFO Occluder, Implantable Device to assess for coronary ischemia, Leadless Pacemakers 2017: Cerebral Protection System 2018: Infrarenal AAA graft (DFU Review), Cardiac Contractility Modulation 2019: Paclitaxel coated drug balloons and stents for LER (Regulatory Action) 2023: Renal Denervation
