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FDA Launches New Device Transparency Web Site

April 22, 2010

In an ongoing effort to provide more transparency, the FDA has launched a new website to provide information about medical device and radiation-emitting product regulations and decisions.  Part of the Center for Devices and Radiological Health (CDRH), it adds a few new overview document, but mainly collects and co-locates a lot of information about the medical device regulatory pathway and the host of medical device databases that exist.

From the press release for the site, FDA CDHR Transparency:

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.
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