FDA Guidance on Inspection of Manufacturing Facilities by Accredited Third Parties

The FDA on September 15, 2005 issued a guidance that provides information and lays down the criteria for requesting inspection of manufacturing facilities by accredited persons under the Inspection by Accredited Persons Program of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002.

Section 201 of MDUFMA, as amended by the Medical Devices Technical Corrections Act of 2004(MDTCA), authorized FDA to establish a voluntary third-party inspection program applicable to manufacturers of Class II and Class III medical devices who meet certain eligibility criteria. Under this Inspection by Accredited Persons Program (AP Program), such manufacturers may elect to have third parties that have been accredited by the FDA conduct some of their inspections instead of the FDA.

The AP program applies to manufacturers who:

Currently market their medical devices (Class II or Class III) in the United States AND
Who market or plan to market their devices in one or more foreign countries and one or both of the following conditions are met:
- One of the foreign countries certifies, accredits, or otherwise recognizes the AP the firm has selected as a person authorized to conduct inspections of device establishments OR
- The firm submits a statement that the law of the foreign country recognizes an inspection by the FDA or by the AP
In their most recent FDA or AP inspection were classified by the FDA as either Voluntary Action Indicated (VAI) or No Action Indicated (NAI)
Submit a notice to the FDA requesting clearance (approval) to use an AP, identifying the AP intended to be used. The FDA should agree with this selection of an AP.

Following the enactment of MDUFMA, FDA accredited 15 APs to perform inspections under the AP program. Most of those APs are still in the process of completing training and may son begin conducting independent inspections under the AP program. The list of APs prepared by FDA is available on the internet at http://www.fda.gov/cdrh/ap-inspection.html#list.

Manufacturers may rely on a single comprehensive inspection or a series of partial inspections that would cumulatively constitute a complete inspection for the purposes of meeting FDA’s biennial inspection requirement.

This new program has its benefits. It confers the manufacturers with greater control over the timing of their inspections. In addition, because some of the APs accredited by FDA are already recognized by other countries as persons authorized to conduct inspections of device establishments, its is possible that in some cases a single AP inspection will meet the requirements of more than one regulatory authority, thereby reducing the need for multiple inspections of the same establishment.

To answer questions relating to your unique requirements and situation, please refer to the FDA Guidance http://www.fda.gov/cdrh/comp/guidance/1532.html for the complete information.

If any questions on the report or comments please email us at info@mdiconsultants.com.

Internet Presence, Creation, Design & Maintenance by: Windco.com, Inc