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Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment

Type: Non-Rule Making
KeyWord(s) Review Clock, Performance Assessment, Premarket Notification, guidance, 510(K), cber
Short title Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
Docket Item Code D
Center CDRH

Primary Documents (1)