News | April 12, 2007

New FDA Web Page Gives Update on Medical Devices

March 13, 2007 - The U.S. Food and Drug Administration's image is so tied to the drug approval process that one of its other duties - the approval and monitoring of medical devices - is often forgotten or misunderstood.

In order to let the public know more about how it approves medical devices and monitors clinical trials on their effectiveness, the FDA has announced a new link on its Web site where the public can keep updated.

The site, called Post Approval Studies, is designed specifically to monitor how well medical devices are performing since their approval, the FDA said in a news release.

"Electronic access will give the public an opportunity to see progress being made on a company's post-market commitments," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in the news release.

The idea for the Web site came in 2005 when the FDA issued a series of reports on post-pediatric medical devices. According to the news release, "Each listing includes the company's name, the product's name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. No information on clinical data is available because the studies may be ongoing and include personal and confidential information."

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