FDA Release Guidance on ISO 13485 Report Pilot Program

24 May 2012 |

In the interests of endeavouring to align its regulatory framework with other GHTF jurisdictions, FDA will introduce a pilot program for voluntary submission of ISO13485:2003 audit reports, with an intended start date of 5 June 2012.

On 19 March 2012, FDA released a guidance which explains exactly how the pilot program will work and the conditions that shall apply. FDA has also recently released additional information in the form of a video and slide presentation, available here.

The program is intended to allow FDA to set “risk-based inspectional priorities” based on the submitted audit reports. The reports will be used to assist FDA in deciding whether an establishment can be removed from FDA’s routine inspection work plan for one year from the last day of the ISO 13485:2003 audit. This in effect will postpone the establishment’s bi-annual inspection for that one-year period.

It should be noted that targeted inspections conducted as part of PMA applications, “for cause” inspections or follow ups to previously conducted FDA audits will continue as per usual and will not be influenced by this pilot program.

Also to be noted is that only audit reports issued by third party auditors under the regulatory system of one of the founding members of the GHTF (Australia, Canada, Europe, Japan) will be accepted by FDA. Internal audit reports will not be accepted. Reports shall only be accepted from establishments which have existing device registrations in USA and who have quality systems compliant with FDA’s Quality System Regulations (QSR – 21CFR Part 820).

In parallel to this initiative, FDA and Health Canada are also working closely to develop a single-audit program whereby one inspection can provide evidence of compliance with both FDA’s QSR requirements as well as Canada’s CMDCAS requirements. There are plans to ultimately expand this initiative to include other GHTF members.

It is encouraging to see these cooperative schemes move forward – it is certainly a welcome idea for manufacturers that they may one day be able to roll their periodic third party quality system audits into one!


Abhi Kannan


UPDATE:  FDA initiated the Pilot program in June 2012. Click here for details

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