The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
Following the Australian Therapeutic Goods Administration’s recent news that Australia, Brazil, Canada and the US will launch a pilot for the Medical Device Single Audit Program (MDSAP) for medical devices in January 2014, The US Food and Drug Administration has provided additional information on its planned participation in the pilot.
During the MDSAP pilot, the FDA will accept MDSAP audit reports as substitutes for the agency’s own routine21 CFR Part 820 quality system inspections. Other participating regulators will treat MDSAP reports as follows:
In the US, regulators will only accept MDSAP audit reports in lieu of routine quality system inspections—any “for cause” or “compliance follow-up” inspections, as well as pre- and post-approval inspections for Premarket Approval (PMA) applications, do not qualify for the MDSAP.