US FDA Further Explains its Pilot Program for ISO 13485 Audits

Following last week's announcement that it would implement a pilot program in June waiving FDA GMP quality system inspections for manufacturers choosing to submit recent ISO 13485:2003 audit reports, the US Food and Drug Administration has published additional explanations of how its new program will work.

The agency has launched an online video, slide presentation and transcript covering issues such as ISO 13485 definitions, voluntary submission requirements, and ISO 13485 audit documents required for participation in the program. If FDA reviewers accept a manufacturer's most recent ISO 13485 audit report, that firm does not have to undergo FDA quality system inspection for one year from the date of its most recent ISO 13485 audit. 

The FDA's pilot program has generated considerable interest--and questions--among medical device industry participants. We should note two important points conveyed in the new material published by the FDA:

  1. The ISO 13485 audit report submission pilot program DOES NOT preclude the FDA from conducting premarket approval (PMA) pre-approval inspections or for-cause inspections.
  2. The FDA is still considering how many consecutive years a participating manufacturer may use this process to satisfy US quality system inspection requirements; how the pilot program works out will factor into this determination.


Based on initial reactions to the pilot program announcement, it is important to reiterate that the program is only available to manufacturers that have already registered their devices for sale in the US and established FDA GMP-compliant quality systems. Furthermore, qualifying manufacturers must  also have ISO 13485 certification in place prior to participation in the program.

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