Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program

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 Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program expires 2021-05-31 and can be found here.