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.
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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.
Source: U.S. Food & Drug Administration
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