Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program." One of the performance goals, referenced in a letter to Congress from the Secretary of Health and Human Services 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 This draft guidance document is intended to assist applicants in understanding the process involved in the bioresearch monitoring (BIMO) review of the clinical and nonclinical information in their premarket approval application (PMA) and the process involved in any related inspections. Premarket notification (510(k)) submissions are not addressed in this draft guidance because a premarket inspection is not ordinarily conducted for 510(k)s. This draft guidance is not final nor is it in effect at this time.