On Jun 5, 2012 the FDA is officially launching ISO 13485 Voluntary Audit Submissions Pilot Program that will allow ISO 13485 certified companies to submit ISO 13485 audit reports from previous 2 years, copy of current ISO 13485 certificate, FDA registration number, company contact information and ISO 13485 auditor information. If the submission is accepted by the FDA, i.e. the compliance status can be established, the manufacturer will be removed from annual FDA inspection list. Inspections conducted ‘for cause’ as well as ‘follow up’ and PMA inspections would not be affected. FDA is still debating how many years in a row this process could be used by a particular manufacturer.

This is great news for manufacturers that are subjected to both ISO 13485 and FDA 21 CFT part 820 inspections; the burden of the inspections will be significantly reduced.

For more information please see FDA guideline on the subject.