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U.S. Department of Health and Human Services

Medical Devices

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Third-Party Inspection (Devices)

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.

Pilot Multi-Purpose Audit Program (PMAP)

On September 7, 2006 the U.S. FDA and Health Canada (HC) mailed a letter to U.S. FDA Accredited Persons for Inspection and HC's Third Party Auditing Organizations, called Canadian Medical Devices Conformity Assessment System (CMDCAS). The letter announces a pilot multi-purpose audit program (PMAP) that will allow qualified auditing organizations in both programs to perform a single inspection that both agencies can use. The purpose of the pilot is to evaluate the effectiveness of performing a single third party inspection/audit of medical device manufacturers' quality systems that would meet the needs and regulatory requirements of both countries.

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