FDA Launches CDRH Transparency Website

The U.S. Food and Drug Administration (FDA) has launched the Center for Devices and Radiological Health (CDRH) Transparency Web site as part of the agency’s transparency initiative, the agency said. The URL is www.fda.gov/ AboutFDA/CentersOffices/CDRH/CDRHTransparency/ default.htm.

The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

The new Web site is part of an ongoing effort within CDRH, and across the FDA to enhance transparency, the FDA said. CDRH’s new Web site provides information in a more user-friendly format.

“The Center for Devices and Radiological Health Transparency Web site gives the public a window into our work,” said CDRH Director Jeffrey Shuren, M.D. “It provides a closer and clearer look at what we do and why we do it.”

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 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

• 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 sources into a single snapshot.

In the coming months, FDA will expand the CDRH Transparency website to include premarket approval and clearance reviews.