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On 5 June 2012, FDA has begun a "voluntary program" for medical devices audits entitled "Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" - based on ISO 13485:2003. Within this program, the FDA will evaluate audit results of device manufacturers according to ISO 13485:2003 in order to set its own risk-based inspectional priorities. The usual 2-year inspection interval should be increased to three in the case of a positive audit result. So-called inspections conducted "For Cause" or "Compliance Follow-up" won't be affected by the program because these are FDA inspections which are performed due to one or several deficiencies. The advantage for the industry is - of course - the extension of the routine inspection interval depending on the respective positive audit result. Who can participate? The program applies for both domestic companies and companies which manufacture outside the USA under the condition that they've sent an audit report to the FDA which is not older than 90 days. The audit must have been performed on ISO 13485:2003 basis under one of the GHTF founding members regulatory systems (e.g. through a notified body). All information submitted under this program should be written in or translated into English.
The entire process is described in a Guidance "Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" which ends on 28 February 2015. Compiled by
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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