FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site

FDA NEWS RELEASE
For Immediate Release: April 19, 2010
Media Inquiries: Dick Thompson, 301-796-7566; dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site
Site contains new information on Center for Devices and Radiological Health decisions

The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today 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 new Web site is part of an ongoing effort within CDRH, across the FDA and across the Department of Health and Human Services to enhance public communication and transparency. CDRH’s previous site provided information about approved products, industry guidance, medical device safety, and adverse event reports. On the new Web site, this and additional information are displayed 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 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 Web site to include premarket approval and clearance reviews.

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

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

For more information:

The FDA’s Transparency Initiative1

The CDRH Transparency Web site2

The HHS Open Government Plan

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FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site