The FDA's Center for Devices and Radiological Health this week launched its website to provide information about medical device and radiation-emitting product regulatory processes and decisions as part of the agency's transparency initiative. "The Center for Devices and Radiological Health Transparency website gives the public a window into our work," says CDRH Director Jeffrey Shuren in a statement. "It provides a closer and clearer look at what we do and why we do it."
CDRH's previous site provided information about approved products, industry guidance, medical device safety and adverse event reports; it now will include additional information displayed in a more user-friendly format. The updated site includes information related to the following topics:
- Premarket submissions for approved and cleared products--summaries of the FDA's review of the documents and data that companies submit to the agency when requesting clearance or approval to market a new or improved device, and the systems the 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 the FDA monitors medical device safety;
- Compliance and enforcement--official actions that the 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; and
- CDRH performance data--metrics about CDRH programs.
The site also features a searchable Total Product Life Cycle database, which integrates premarket and postmarket medical device information from multiple data sources into a single snapshot.
In the coming months, the FDA will expand the CDRH Transparency website to include premarket approval and clearance reviews. It also includes a feedback feature that will allow the FDA to collect input and suggestions from the public about the information provided.
- see the CDRH announcement