FDA Launches New Device Transparency Web Site

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.

Link: FDA CDRH Transparency.