QSR Requirements: What’s Behind FDA’s Increasing Focus on Them?

Q: It seems like FDA is paying much more attention today on device makers meeting the QSR requirements found in 21 CFR Part 820. What are the implications of that level of attention — for both industry and the Agency?

A: One of the keys is that the QSR requirements are pretty much in line with the international ISO standards. As FDA has published more guidance and has internally changed its enforcement approaches, some of the more obvious changes have occurred.Today, you see FDA putting more emphasis on the European style of encouraging industry to cooperate and comply — so there’s more focus on voluntary compliance.

At the same time, industry — because of the pressure being applied internationally — is becoming more compliant with what’s essentially a single set of standards. QSR isn’t quite the same as the rest of the world, but it is a similar set of standards. Because of that, the pressure is now on industry, and it’s finally deciding not to fight all these things; it needs to go ahead and comply as best it can. So there is renewed interest by industry in meeting the QSR requirements.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]FDA has been trying to get a better handle on recalls and encouraging industry to do things to prevent recalls.[/pullquote]

We’ve also seen quite a few changes by FDA in recent years to certain aspects that were contentious before – such as what is validation and that kind of thing. FDA actually has tempered some of its views. It has been a decade-long drift for FDA, but especially in the past couple of years, the Agency has been trying to get a better handle on recalls and encouraging industry to do things to prevent recalls. Most of the recalls have been QSR-related, so FDA is looking for more cooperative mechanisms to get compliance. That fosters a better attitude on the part of industry too. If it knows the Agency is going to work with manufacturers a bit more than previously, industry tends to try to comply a little more.

Answered by Martin Browning, EduQuest President and Co-Founder (22 years as an FDA investigator and the co-developer of the Quality System Regulation — 21 CFR 820 — when he served as the Special Assistant to FDA’s Associate Commissioner for Regulatory Affairs). Martin also is the chairman of EduQuest’s 2-day QSR Compliance Basics training class.

This Q&A is excerpted from a two-part interview with Martin Browning published in August 2013 by Medical Device Daily: The Daily Medical Technology News Source (www.medicaldevicedaily.com).

If you’d like a PDF copy of the entire two-part interview, entitled “Change is Imminent as FDA, Industry Forge New Relationship” and “Regulating Interfaces is a Can of Worms for FDA“, email EduQuest.


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