By Neil O’Flaherty, partner at Amin Wasserman Gurnani LLP
U.S. Good Manufacturing Practices (GMPs) for medical devices are poised to change. It’s been a minute: The last time GMPs for medical devices occurred in 1996 – almost three decades ago.
HOW ARE DEVICE GMPS CHANGING – AND WHEN?
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal Register that amended the current Quality System Regulation (QSR) (21 C.F.R. Part 820) to more closely follow the widely used international consensus standard of ISO 13485 (See Medical Devices; Quality System Regulation Amendments, 89 Fed. Reg. 7496 [Feb. 2, 2024]. Federal Register : Medical Devices; Quality System Regulation Amendments).
This final rule amends the QSR by specifically incorporating by reference the requirements and concepts of ISO 13485 and part of ISO 9000. The exact provisions incorporated by reference are:
• ISO 13485:2016(E) (ISO 13485), Medical devices—Quality management systems—Requirements for regulatory purposes, Third edition, March 1, 2016; and
• ISO 9000:2015(E) (ISO 9000), Quality Management systems—Fundamentals and vocabulary, Clause 3—Terms and definitions, Fourth edition, September 15, 2015.
The final rule also amends the title of the QSR to “Quality Management System Regulation” (QMSR). The final rule takes effect February 2, 2026.
FDA’s QSR is similar to, but not exactly the same, as ISO 13485. The new final rule continues FDA’s efforts to more closely align its device regulatory regime with those used by other foreign device regulatory authorities.
In light of the planned transition from the QSR to the QMSR, FDA will be developing a new inspection process to align with the new QMSR and train its relevant employees on the new process.
FDA will begin to enforce the QMSR requirements on February 2, 2026, and until then, device manufacturers will only be required to comply with the QSR. According to FDA, any future revisions to the ISO 13485 standard would need to be evaluated by the Agency to determine the impact of the changes and whether the QMSR should be amended to account for them.
HOW SHOULD COMPANIES PREPARE?
Device manufacturers should be taking actions now to comply and be in the best position to protect themselves prior to the start of the new rule by:
1. Clearly understand what the changes are. The starting point is to clearly understand how the QMSR is different from the current QSR. Besides reading and digesting the final rule itself, device manufacturers should read and digest FDA’s guidance document entitled “Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions (Nov. 21, 2025). Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions | FDA. Without a clear understanding of the differences, it is not possible to understand how they impact your current quality system under the QSR.
2. Determine how the QMSR changes impact your current quality system. Device manufacturers should create a list of the impacts of the QMSR changes on its current QSR quality system. What aspects of your quality system need to be revised? What additions need to be made? Understanding the necessary revisions and additions is crucial to preparing a plan to implement them.
3. Prepare an implementation plan. Having a documented implementation plan allows a device manufacturer to make needed revisions and additions in an organized fashion. It also allows the manufacturer to track progress on the plan until full implementation.
4. Implement the plan and confirm its effectiveness. Besides implementing the plan, device manufacturers should assure that the steps taken under the plan actually result in QMSR compliance.
5. Train relevant employees. Educate your employees on the QMSR changes and how the company has addressed the needed revisions and additions with its implementation plan. Relevant employees should understand what is expected of them to maintain QMSR compliance.
6. Understand FDA’s new QMSR inspectional approach. Look for, review and understand new documents or other pronouncements by FDA regarding its new QMSR inspectional approach. This will allow device manufacturers to optimize their inspection readiness under the QMSR.
7. Stay up to date. Device manufacturers should keep abreast of possible and actual changes to the QMSR and the Agency’s QMSR inspectional approach after February 2, 2026. Change is almost inevitable. Device manufacturers must remain vigilant and react to changes as necessary.
The QMSR will take effective February 2, 2026. If you have not already, now is the time to focus on the QMSR changes and take steps to achieve QMSR compliance and inspection readiness by the effective date.
– This entry for AAMI’s new Insights into Innovation perspectives series is authored by Neil O’Flaherty, a partner at the law firm of Amin Wasserman Gurnani LLP. The opinions presented here are solely those of the author and do not reflect the position of AAMI or AAMI Foundation.
