Accredited Persons Inspection Program - Third Party Inspection

[Aaron Lupo]

Accredited Persons Inspection Program

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law on October 26, 2002. Section 201 of MDUFMA establishes a new subsection "g" to section 704 (Factory Inspection) of the FDCA, 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. Additional information, including a list of authorized Accredited Persons, can be found at Accredited Persons Inspection Program.


If you would like more information you can visit: http://www.fda.gov/cdrh/ap-inspection/

This is likely to keep FDA out of your facility.