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Healthcare Business News

New FDA website on devices, radiation products

By Shawn Rhea
Posted: April 19, 2010 - 3:00 pm ET

The Food and Drug Administration has launched a new website to provide information on the agency's regulatory actions on medical devices and radiation-emitting products.

The website, which focuses on regulatory responsibilities covered by the Center for Devices and Radiological Health, is part of the FDA's ongoing transparency initiative, agency officials said. This “website gives the public a window into our work,” center Director Jeffrey Shuren said in a news release.

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The website features a variety of product updates, including the status of premarket submissions and post-market performance and safety information; compliance and enforcement actions taken by the agency; and details on CDRH-sponsored research.

The site also features a searchable Total Product Life Cycle database, which aggregates pre-market and post-market information on individual products from a number of sources. The site eventually also will post pre-market approval and clearance reviews.



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