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21 CFR 820 for QSR is a US regulation- not an option

These days we read a lot about the US FDA “incorporating” ISO 13485. The US Food and Drug Administration proposed a rule in early 2022 to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard and as a result some companies decided they did not need to worry about the US regulations. Well, it has finally happened, sort of. So, what does the latest announcement of “incorporation” mean to you?

Too many folks are over interpreting the FDA intentions; assuming that if their company complies with ISO 13485:2016 they are home free with the FDA. But the key word is INCORPORATING. 21 CFR 820 is a regulation and is not likely to go away since it is a manner of executing a federal law.i

Federal Register 89 FR 7496 announcedii that FDA is incorporating by reference the International Standard, ISO 13485:2016(E), Medical devices—Quality management systems—Requirements for regulatory purposes, “Third Edition, 2016–03–01. ISO is an independent, nongovernmental international organization with a membership of national standards bodies. ISO 13485 specifies requirements for a QSM that can be used by a manufacturer involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, or provision of associated activities.“ (That is a mouthful and bears careful examination.)

Even though this change does not become effective until February 2026, because many companies review and reissue SOPs on a revolving basis, this announcement is cause for some quick assessment, even now. We will watch carefully how FDA inspectors interpret the phrase: “incorporate by reference.” Notice also that this Federal Register notice has cited: ISO 13485:2016(E), Third edition (2016-03-01). Us standards-junkies know full well that all ISO standards undergo periodic review, so this version is already out of date: There is an ISO 13485:2023! (So, what does FDA do about that? Revisions are great, or are they? What if the standard is changed in some way that is not good for us?)

FDA states: We are also publishing additional requirements that help connect and align ISO 13485 with other FDA requirements. (So, you see– it is NOT identical to ISO 13485.)

Federal Register states: We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. While the QS regulation provided sufficient and effective requirements for the establishment and maintenance of a QMS, regulatory expectations for a QMS have evolved since the QS regulation was implemented over 20 years ago. “By incorporating ISO 13485 by reference, we are explicitly requiring current internationally recognized regulatory expectations for QMS for devices subject to FDA’s jurisdiction. This resulting regulation is referred to as the QMSR.

And if you are not sufficiently confused yet, read this: “We recognize, however, that reliance on ISO 13485 without clarification or modification could create inconsistencies with FDA’s statutory and regulatory framework. Therefore, as detailed in this rulemaking, we are adding additional definitions and provisions.” (See, FDA is NOT ADOPTING ISO 13485, they are making their own rules.) In fact, the fine print states: “Where possible, we either are accepting the incorporated requirement without modification or are creating a requirement that will supersede the correlating requirement in ISO 13485” (Have you got that???)

FDA has accepted ISO 13485 audit reports from manufacturers who are under the MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP), but that is a different arrangement altogether.iii

Paladin Medical, Inc. has provided template quality system procedures and forms for our clients for many years and will continue to do so as the new QMSR is implemented. This will take time and careful consideration. Stay tuned to this site.

To remember another great American icon: Yogi Berra: It ain’t over till it’s over.