FDA Details Appeals Process For Rejected Medical Devices

Law360, New York (May 16, 2013, 2:10 PM EDT) -- The U.S. Food and Drug Administration on Thursday described how it would handle appeals of the agency denying approval of new medical devices, generally declining to back off its expectation that manufacturers work through the chain of command when contesting outcomes.

In its finalized guidance, the FDA’s Center for Devices and Radiological Health said that a device maker should engage with reviewers directly before pursuing a formal appeal, asserting that “discussion and agreement” are typically the most effective means of resolving disputes.

That direction essentially rebuffs...
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