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CDRH Looks For Input On Guidance-Development Practices

This article was originally published in The Gray Sheet

Executive Summary

FDA’s device center will seek feedback on its guidance development process and best practices at a June 5 workshop.

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Industry Proposes Its FDA Guidance Priorities, Reforms

After FDA published its annual lists of guidance priorities, industry has responded by stating what guidances companies would like to see. Meanwhile, the push for broader reforms to the guidance-development process continues.

CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity

The device center has committed to metrics for draft guidance documents, trying to address complaints that policies linger too long in the draft stage and create regulatory confusion.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.

Draft Guidance Docs Should Be Transitory, Industry Insists

Device industry advocates stressed to CDRH during a meeting last week that draft-guidance documents need to more routinely be finalized or withdrawn in an expedited manner, and that agency staffers must resist using the out-for-comment document as if they are settled policy.

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