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Draft Appeals Guidance Does Not Address Industry’s Main Concerns, Says Device Attorney

FDA’s new draft guidance explains the various routes to appeal a CDRH decision, but doesn’t do much to reform the appeals process, according to one device attorney.

FDA’s recently issued draft guidance on appealing device center decisions doesn’t address industry’s key complaints – the slowness of the appeals process and conflicts of interest among FDA appeals reviewers – a device attorney says.

The Dec. 27 draft guidance describes the various avenues for appeals, including requests for supervisory review, use of the Medical...

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