Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. Please join us for a free one-hour webinar on MDSAP, March 28th.
Medical device firms, are you looking forward to your next FDA inspection? I have conducted around 400 of them, and I am still trying to think of an instance when the firm was happy to see me. I never took it personally. FDA inspections can be stressful, not to mention they are very expensive and time consuming to support. Furthermore, FDA inspections are often followed by an unpleasant period of uncertainty regarding outcomes and adequacy of responses.
What if I told you that in your next “FDA Inspection” you would have ample advance notice; and you would know to a high degree of certainty what the duration and topical coverage of the inspection would be?
What if you also knew in advance how adverse findings would be reviewed and categorized with respect to severity?
Toss in an established timeline for feedback regarding the adequacy of your post inspection response, more formal controls on the technical and auditing competency of the auditor, and defined appeal mechanisms.... does that sound a little better? Now consider the possibility of this inspection satisfying your conformity assessment requirements for multiple regulatory jurisdictions simultaneously. Additionally, what if the applied audit model was well aligned with expectations of third party QMS standards you already have in place?
Oh, and if you are selling in Canada, you will soon have to do this inspection anyway.
The situation I've just described hypothetically is much closer to reality as a result of the Medical Device Single Audit Program (MDSAP). If you haven’t heard about it yet, MDSAP is a program that would allow a single inspection by a recognized Audit Organization (AO) to satisfy audit requirements for multiple global regulatory authorities, and would serve as a substitute for routine FDA inspections. FDA went live with the MDSAP program January 1, 2017. Other participating nations include Canada, Brazil, Australia and Japan. The MDSAP program will be a mandatory replacement for the Canadian Medical Device Conformity Assessment System (CMDCAS) effective January 1, 2019.
There is a lot to like about the program, including the program's highly prescriptive audit model. But life is never simple – MDSAP is emerging, and there is limited data on MDSAP participant experiences. And the risk-to-benefit trades may be highly dependent on a firm or site’s specific situation - including markets you are in, the status of your QMS, your existing relationships with AOs, and your current comfort level with FDA performed inspections.
I invite you to join us at an upcoming R&Q Intelligence Series webinar on this very subject on Tuesday, March 28th 2017 at 1:00pm EST.
Medical Device Single Audit Program (MDSAP)
What is it? Is it for me? How will I get it done in time?
Subject matter experts with first-hand experience will overview the MDSAP program, discuss the pros and cons, and talk about how to get ready in the event the program makes sense for you. I am personally excited about this topic and look forward to receiving feedback on how others view the MDSAP program.
I hope you can join us.