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  1. Device Advice: Comprehensive Regulatory Assistance

Third-Party Inspection (Devices)

Third-Party Inspection (Devices)

Medical Device Single Audit Program (MDSAP)

From January 1, 2014 to December 31, 2016), FDA collaborated with international partners to participate in the Medical Device Single Audit Program (MDSAP) Pilot. The MDSAP Pilot allows an MDSAP-recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (that is, the international MDSAP governing body) determined that the MDSAP Pilot satisfactorily demonstrated the viability of the program. Since January 2017, the MDSAP has transitioned from pilot to fully operational status. FDA will continue to accept MDSAP audit reports as a substitute for routine FDA inspections.

Accredited Persons Inspection Program

The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 was signed into law on October 26, 2002. Section 201 of MDUFMA establishes a new subsection "g" to section 704 (Factory Inspection) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which requires FDA to accredit third parties (Accredited Persons) to perform inspections of eligible manufacturers of Class II or III devices. This is a voluntary program. While all firms remain subject to inspection by FDA, eligible manufacturers have the option of requesting inspection by an Accredited Person (AP). However, inspections by APs are limited to manufacturers who meet certain conditions under Section 704(g0(6)(A) of the FD&C Act.