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CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity

The device center has committed to metrics for draft guidance documents, trying to address complaints that policies linger too long in the draft stage and create regulatory confusion. CDRH also highlighted recent website upgrades intended to better distinguish between draft and final guidance documents.

FDA's device center has established time-based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long.

For 80 percent all draft guidance documents issued Oct. 1, 2014, or after, CDRH says it will commit to finalizing or withdrawing the draft, reopening a comment period or issuing...

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