Home » FDA Provides Draft Guidance on Refuse to Accept Policy for 510(k)s to Replace Existing Guidances
FDA Provides Draft Guidance on Refuse to Accept Policy for 510(k)s to Replace Existing Guidances
The FDA released a draft guidance, entitled “Refuse to Accept Policy for 510(k)s,” that seeks to clarify and ultimately replace existing policy documents explaining when a medical device premarket notification (510(k)) submission is administratively complete and ready for substantive review.
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