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Third Party Inspections

The Medical Device Annex of the U.S./EC Mutual Recognition Agreement:

On June 20, 1997, the U.S. and the European Community (EC) signed a mutual recognition agreement (MRA) which covers a variety of product sectors including telecommunications, electrical safety, recreation craft, pharmaceuticals and medical devices. The aim of this agreement is to facilitate transatlantic trade while reducing costs for compliance with regulatory requirements. This agreement became effective December 1, 1998 and initiated a transition period during which time both sides engaged in confidence building activities. When sufficient confidence building activities are completed enabling each side to list a significant number of CABs, the agreement will become operational.

In addition to Premarket Notification 510(k) review, the medical device annex covers the exchange of quality systems evaluation/inspection reports for medical devices manufactured in the European Union. A European CAB can conduct inspections for most (Class I, II, and III) classes of devices except in vitro diagnostic devices based on FDA requirements.

Additional information on the U.S./EC MRA and on specific European CABs can be found on the Internet at http://www.fda.gov/cdrh/mra/index.html.

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.

Updated October 24, 2003

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