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 guidance entitled "Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002." The Medical Device User Fee and Modernization Act of 2002 authorizes FDA to establish a voluntary inspection program under which manufacturers of class II or class III devices who meet certain eligibility criteria as defined by the statute can elect to have FDA-accredited third parties conduct some of their establishment inspections instead of FDA. This guidance document describes the establishment eligibility criteria and the process for establishments to follow when requesting FDA's approval to have an accredited person (AP) conduct an inspection of their establishment instead of FDA under the new Inspections by Accredited Persons Program (AP Program).