New tools of the trade.
The author reviews the regulatory process through which new cardiovascular interventional devices reach the hands of the interventional radiologist and the cardiologist. The marketing mechanisms are outlined, as are the data requirements. The reader is taken step-by-step from device investigation conducted under an approved investigational device exemptions application to market clearance, through either a substantially equivalent 510(k) notification or an approved premarket approval application, and beyond, including how to report adverse device experiences through the Medical Device Reporting REgulation and the Medical Device and Laboratory Product Problem Reporting Program.
Center for Devices and Radiological Health, Division of Cardiovascular Devices, Rockville, MD 20857.
L A
LA
Reamer
D002986:Clinical Trials as Topic; D006801:Humans; D007883:Legislation, Medical; D015642:Radiology, Interventional / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration