Draft Guidance for Industry, Food and Drug Administration Staff, and Food and Drug Administration-Accredited Third-Parties: Requests for Inspection by an Accredited Person Under the Inspections by Accredited Persons Program Authorized by the Medical Device User Fee and Modernization Act of 2002; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Requests for Inspection by an Accredited Person Under the Inspections by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002." Section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes FDA-accredited third parties (accredited persons or APs) to conduct inspections of manufacturers of class II and class III devices who meet certain eligibility criteria as defined by the statute. This draft guidance document describes the establishment eligibility criteria and the process for establishments to follow when requesting FDA's approval to have an AP conduct an inspection of their establishment instead of FDA under the new inspections by accredited persons program (AP program).