The Food and Drug Administration has launched a new website to provide information about medical device and radiation-emitting product regulations and decisions. The website is a part of the Center for Devices and Radiological Health (CDRH).
From the press release:
The site includes information related to the following topics:
Premarket submissions for approved and cleared products – summaries of FDA’s review of the documents and data that companies submit to FDA when requesting clearance or approval to market a new or improved device, and the systems FDA uses to evaluate these submissions. Postmarket performance and safety – documents and data describing how well devices perform after they are on the market, and information about how FDA monitors medical device safety. Compliance and enforcement – official actions that FDA has taken in response to problems with devices or device companies. Science and research – research programs at CDRH or sponsored by CDRH. Educational resources – information to help industry and others understand CDRH requirements and processes. CDRH performance data – metrics about CDRH programs.
Full press release: FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site…
Link: FDA CDRH Transparency…