FDA Releases Draft Guidance for Industry: Requests for Inspection by Accredited Person Under AP Program

Summary

The Food and Drug Administration (FDA) has released a draft guidance document outlining the process for manufacturers of class II and class III medical devices to request an accredited person (AP) conduct an inspection of their facility instead of an FDA inspection. The guidance aims to facilitate the FDA's new inspections by accredited persons program, authorized by the Medical Device User Fee and Modernization Act of 2002.