[2025-08-27] In February 2024, the US Food and Drug Administration (FDA) published its final rule on the transition from the QSR (QS Regulation) to the QMSR (Quality Management System Regulation).
This transition, intended to bring the regulations into line with ISO 13485:2016 and facilitate international harmonization, aims for an application date of February 2, 2026.
In this context, on August 27, 2025, the FDA published a Frequently Asked Questions document designed to answer the main questions raised by stakeholders.
The 14 questions are as follows:
- Why is the FDA taking this action?
- What is the FDA doing to prepare for harmonization of the Quality System regulations with ISO 13485?
- What training will FDA staff do?
- How will this rule impact FDA staff and programs?
- Now that FDA has incorporated ISO 13485:2016, what happens if the standard is revised?
- When will the new regulation be effective?
- Will FDA start enforcing the QMSR on February 2, 2026?
- What records does the FDA intend to review during inspections conducted on or after February 2, 2026?
- On or after the QMSR effective date of February 2, 2026, does FDA intend to review records that were previously exempt from review under QS Regulation 820.180(c) (e.g., internal audits, supplier audits, and management review reports)?
- Will there be a new inspection process?
- Where do I find information about the new inspection process for QMSR?
- How should a manufacturer prepare for an FDA device inspection that occurs on or after February 2, 2026?
- How does a medical device manufacturer obtain access to the two standards that have been incorporated by reference in the QMSR, namely, ISO 13485:2016 and ISO 9000:2015 Clause 3?
- How will FDA device inspections under the QMSR compare to Medical Device Single Audit Program (MDSAP) audits?
It is interesting to note, in response to question 13, that the FDA provides free read-only access to ISO 13485:2016 and ISO 9000:2015 after registration.
The transition to QMSR marks a key stage in the harmonization of US requirements with ISO 13485, the widely used and recognized standard for quality management systems.
Article written by Karim Chelly, member of the DMEXPERTS network.