FDA clarifies existing guidance on medical-device appeals

05/17/2013 | MassDevice.com (Boston)

Draft guidance issued by the FDA aims to explain its existing guidelines for medtech companies seeking to appeal the regulatory actions and decisions of the agency's device center. The proposal is up for comment for 90 days and will be added as an appendix to the FDA's current appeals guidance when finalized.

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MassDevice.com (Boston)

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