Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations." One of the performance goals, referenced in a letter that accompanied the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) legislation, includes a commitment to improve FDA's scheduling and timeliness of preapproval inspections. This draft guidance document is intended to assist manufacturers in preparing for FDA's review of their premarket approval application (PMA) manufacturing section and in the coordination of the preapproval inspection of the manufacturing operations described in the PMA or PMA supplement. This draft guidance document does not address premarket notification (510(k)) submissions because a premarket inspection is not ordinarily conducted for 510(k) submissions. This draft guidance is not final nor is it in effect at this time.