By February 2, 2026, medical device manufacturers will need to be fully compliant with the Quality Management System Regulation (QMSR), which replaces the existing Quality System Regulation (QSR) under 21 CFR Part 820. This isn’t just a paperwork update, it signals a substantial shift in FDA expectations, international alignment, and what “quality system compliance” means in practice.
On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practices (CGMP) requirements of the Quality System Regulation (QSR, 21 CFR 820), incorporating by reference the international standard ISO 13485:2016. The update regulation is titled the “Quality Management System Regulation (QMSR),” with enforcement beginning February 2, 2026.
Figure 1. Changes in Content Structure from QSR to QMSR
Harmonization: FDA explicitly states that the QMSR aligns U.S. device regulatory requirements more closely with internationally accepted standards, primarily ISO 13485:2016, which outlines the guidelines for quality management systems in the design and manufacture of medical devices.
Consistency & Reduced Burden: For manufacturers already compliant with ISO 13485, this change aims to reduce regulatory overlap and facilitate global market access.
Modernization: Many parts of the existing QSR (from 1996) have aged. The transition to QMSR incorporates the FDA’s current thinking on risk-based decisions, terminology, documentation, and aligns with the evolving global regulatory expectations.
The transition from QSR to the QMSR is the Federal Food, Drug, and Cosmetic Act (FD&C Act) under which FDA is authorized to set CGMP requirements for medical devices. The rule is codified in 21 CFR Part 820, as amended, and included conforming edits to Part 4 (21 CFR Part 4) for combination products. ISO 13485:2016 is incorporated by reference. It should be noted that future revisions to ISO 13485 will not automatically be incorporated, as the FDA will evaluate them, and if needed, will amend the regulation through rule making.
ISO Certified Doesn’t Mean Your QMSR Compliant
The FDA states that even if you're already ISO 13485 certified, ISO certification alone is not sufficient to ensure compliance with QMSR and will not exempt you from FDA inspections. There are U.S.-specific provisions, definitions, and regulatory expectations that must be satisfied.
FDA Intends to Review Previously Exempt Records
All relevant records, including management review, internal audits, supplier audits, will be in scope under QMSR for FDA inspection, even if some of these were previously exempt under QSR. The preamble of the final rule outlines that relevant records should already be maintained in normal business operations and should be easily accessible upon inspection.
A New Inspection Process Will be Implemented
Inspections themselves will change, as the Quality System Inspection Technique (QSIT) will be withdrawn, and will be replaced by new inspection methods under QMSR. The QMSR inspection process will be available no later than February 2, 2026, and will be outlined in a revised version of the Compliance Program (CP) Inspection of Medical Device Manufacturers.
1. Perform Gap Analyses: Start gap analyses now, focusing not just on obvious items (e.g. documentation) but on definitions, process consistency, risk throughout lifecycle, supplier management, labeling/packaging.
2. Engage Your Senior Leadership: If you haven’t already done so, involve your management team, otherwise known as “top management,” in ISO / QMSR terms, early so culture, resources, and oversight are aligned.
3. Plot a Roadmap: Based on the findings of your gap analyses, develop a plan for remediating any deficiencies found that must be addressed by the QMSR effective date such as internal audit, training, policy / document updates, mock inspections, supplier readiness, etc.
The QMSR isn’t just another regulatory update, it is a foundational shift in how FDA will monitor, inspect, and hold companies accountable. The lead time is finite. For firms that move early and with discipline, this is an opportunity to strengthen quality, streamline compliance globally, and reduce risk. For those who wait, the gap may be costly.
With the February 2, 2026 deadline quickly approaching, now is the time to act. At Rook Quality Systems, our seasoned consultants specialize in:
Conducting QMS gap analyses to identify ISO 13485 and QMSR compliance gaps
Developing and implementing transition roadmaps tailored to your organization
Updating documentation, SOPs, and labeling/packaging controls for QMSR readiness
Providing training and audit support to ensure smooth FDA inspections