FDA's device center increases focus on post-approval studies

01/29/2008 | Medical Devices Today

The FDA's Center for Devices and Radiological Health is increasing focus on postmarket studies, as evidenced by its request to Medtronic to conduct two post-approval follow-up studies on its X-Stop spinal implant, the company's clinical executive said. The agency has made major changes in its post-approval study program, including changes regarding review functions and monitoring post-approval study commitments, a CDRH Office of Surveillance and Biometrics official said.

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