RAPS 2013 Series: MDSAP

Of all of the seminars I attended at the RAPS 2013 Conference in Boston, the Medical Devices Single Audit Program ("MDSAP") was arguably the best. The overview of MDSAP - done well by Kim Trautman of the FDA and Mike Ward from Health Canada - was thorough and well done; however, it was the overall conclusion and closing remarks from Elisabeth George of Philips Healthcare and Paul Brooks of BSI that made this an engaging session.

For any readers unfamiliar with the program, the MDSAP was created to address the growing need to harmonize regulatory auditing efforts across the world. The initial MDSAP participant countries include Australia (Therapeutic Goods Administration - TGA), Canada (Health Canada and the CMDCAS system), Brazil (ANVISA), and the United States (US Food and Drug Administration). The European Union is also included on the working group but is not part of the initial pilot of the program, and Japan is listed as an official observer and subject matter expert. The idea behind MDSAP is to have one audit sufficiently address the needs of the four countries involved in the pilot studies. This hopefully eases a lot of regulatory pain - manufacturers do not need to allocate many weeks a year to external audits and regulators can streamline surveillance activities (especially as word has it that ANVISA has a waiting list that will take years to clear). Here is some light reading for those curious to learn more:

IMDRF MDSAP Site

FDA MDSAP Site

FDA MDSAP Program Progress Report

The pilot for the auditing organizations to participate will begin in January 2014 with an expectation that manufacturers can be audited under the MDSAP program in June of 2014. It is with an understanding of this soon-to-arrive pilot that I offer this advise: read up on the program, set a plan, and participate.

I understand the hesitancy to enter into any pilot program with the FDA as manufacturers prefer to take a minimalist stance to their communication with the agency. The ISO 13485 audit report pilot program was one example where R&Q heard of a large number of manufacturers shaking their heads because they saw no reason to participate. This program is worth it, and wide-spread participation is the key.

Paul Brooks and Elisabeth George both focused a lot of their time talking about adoption. Mr. Brooks, in particular, mentioned a number of harmonization projects that fizzled at least partially because of lack of participation. Ms. George made mention that MDSAP is an opportunity for industry to have input on how our companies will be regulated, and advised the attendees to take advantage of this opportunity. The time savings provided by MDSAP alone may be enough to motivate participation as many understand the time-sink that occurs when an FDA inspection falls closely to a notified body surveillance or certification audit. The panel's overall message: PARTICIPATE!

-RTK