FDA Approves Final MDIC Report on MedAccred’s Sterilization Audit and Accreditation Program

On December 13, 2024, the U.S. Food and Drug Administration (FDA) notified the Medical Device Innovation Consortium (MDIC) of their final approval of the MDIC Report on the MedAccred Accreditation and Audit Program for Contract Sterilizers (Final Report). FDA inspections of firms, such as contract sterilizers, are pursuant to Title 21-Food and Drugs, Chapter 9 – Federal Food, Drug, and Devices, Part A-Drugs and Devices, Section 21 USC 360: Registration of producers of drugs or devices, Subsection (h) Inspections.1 The FDA notification is the culmination of a pilot study initiated by the Performance Review Institute (PRI) in 2023 in collaboration with MDIC and the FDA to evaluate PRI’s MedAccred Sterilization Audit and Accreditation Program of contract sterilizers. The agency confirmed that MedAccred is as an acceptable audit approach that may be leveraged for regulatory purposes as well as supplier oversight.