Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002

Information from this collection will be used by FDA to implement an Inspection by Accredited Persons program that will train and accredit persons that wish to conduct inspections of eligible manufacturers of class II and class III medical devices. This action is required by MDUFMA. This ICR collects information from manufactures of class II or class III medical devices who meet certain eligibility criteria and who intend to use an "accredited person" to conduct an inspection of their establishment. Under the Inspection by Accredited Persons Program, eligible manufacturers may elect to have third parties that have been accredited by FDA conduct some of their inspections instead of FDA. This program allows manufacturers greater control over the timing of their inspections and, in some cases, may reduce the need for multiple inspections of the same establishment.

The latest form for Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 expires 2022-08-31 and can be found here.

Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

Federal Enterprise Architecture: Health - Consumer Health and Safety