US FDA Launches Medical Device and Radiation-Emitting Product Transparency Website

The US Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency website on 19 April as part of the agency’s transparency initiative. 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 website is part of an ongoing effort within CDRH, across the US FDA and across the Department of Health and Human Services to enhance public communication and transparency in the United States. CDRH’s previous site provided information about approved products, industry guidance, medical device safety, and adverse event reports. On the new website, this and additional information are displayed in a more user-friendly format.

“The Center for Devices and Radiological Health Transparency website gives the public a window into our work,” says 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 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 data sources into a single snapshot.

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

The website includes a feedback feature that will allow FDA to collect input and suggestions from the public about the information provided.

“The website launch is only a beginning for transparency efforts within the Center for Devices and Radiological Health,” says Shuren. “We encourage the public to explore the site and share feedback so that we can continue to expand our efforts and make improvements.”

The URL for the site is www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/default.htm.

Tags: CDRH, Center for Devices and Radiological Health, FDA, US FDA, US Food and Drug Administration