FDA Issues Preliminary Reports on the 510(k) Program and Use of Science in Decision Making for Medical Devices

AGG Partners William H. Kitchens and Alan G. Minsk and Associate Lanchi Nguyen authored a client alert on proposed changes to medical-device approval that ran in full on BioSpace, an online community for the life sciences industry. The alert describes proposed changes to the 510(k) program, which is the primary method in the U.S. for granting market authorization to medical devices. The changes are intended to foster device innovation, enhance regulatory predictability and improve safety. The article focuses on ten specific recommendations contained in two preliminary reports. The reports were issued in response to concerns both within the agency and in the general community about weaknesses in the current 510(k) program. FDA believes the recommendations will help streamline the process for bringing innovative medical technologies to patients and facilitate medical-device development to address unmet public health needs. Following a period of public comment, FDA will decide which changes to pursue. Please click here to read the article.