What Changed for Medical Device Manufacturers in 2026?
The FDA has incorporated ISO 13485 into 21 CFR Part 820, now referred to as the Quality Management System Regulation (QMSR).
Where can I find FDA QMSR resources?
The FDA provides a useful resource page for the medical device industry, including the published QMSR, which you can download here:
You can also email questions to: Proposed-Device-QMSR-Rule@fda.hhs.gov.
For nearly 30 years, medical device companies outside the U.S. lived and breathed ISO 13485. Then, on February 2, 2026, Groundhog Day, the FDA finally crawled out of its burrow and joined the party.
The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates by reference much of ISO 13485:2016. ISO 13485 now provides a framework for medical device manufacturers to build their quality management systems (QMSs). Although the QMSR incorporates portions of ISO 13485:2016 and Clause 3 of ISO 9000:2015, it retains country-specific requirements.
This is wonderful news for manufacturers of most medical devices, but please note that nothing has changed regarding the requirements for medical device combination products. Those products still have their own regulations. Please see:
https://www.fda.gov/combination-products/guidance-regulatory-information
Medical device organizations must understand not only the structure of ISO 13485 but also how the FDA evaluates quality systems during inspections. The old inspection process, the Quality System Inspection Technique (QSIT), is gone. It has been replaced with the FDA Compliance Program Manual 7382.850, which is aligned with the QMSR and can be downloaded here:
What inspection manual is the FDA using for medical device inspections?
The FDA is currently using Compliance Program Manual 7382.850, published on February 2, 2026. You can download it here:
What are the major changes with medical device FDA inspection manual 7382.850?
FDA inspectors will now be able to review records they previously could not review, including:
- Management reviews
- Internal audits
- Supplier audits
- Evidence that risk-based decision-making exists at the leadership level
This is not new from a notified body perspective, but it will be new for manufacturers that have mainly dealt with the FDA.
What has the FDA not changed with medical device FDA inspection manual 7382.850?
The following areas remain important:
- Labeling
- Complaints and complaint handling
- Adverse event reporting and Medical Device Reporting (MDR)
- Corrections and removals
- Recalls
- Unique Device Identification (UDI)
- Servicing activities
- Design controls
- Production processes
- Supplier controls
What are the key differences between ISO 13485 and U.S. FDA QMSR under 21 CFR Part 820?
The QMSR is the FDA’s official adoption of ISO 13485:2016 as the new foundation for 21 CFR Part 820.
The FDA now places strong emphasis on system effectiveness, data integrity, and patient risk rather than simply confirming that procedures exist and that records show they were followed. Auditors typically see that, for example, five companies with similar documented procedures may receive very different inspection outcomes depending on how consistently their procedures are implemented, how thorough their records are, and how well they perform under real-world conditions.
Will ISO 13485 certification be enough for FDA inspections after 2026?
No. The QMSR formally adopted ISO 13485, but the FDA layered its own requirements on top rather than replacing them.
Inspectors will typically assess:
- Complaint handling, trending, and escalation
- CAPA effectiveness, timeliness, and closure
- Management oversight, including decision-making and resource allocation
For example, a company may hold an ISO 13485 certificate, but it could still receive inspection observations if complaint data is not adequately analyzed and vigilance reporting is not performed. In these cases, the issue is not the absence of procedures but the lack of objective evidence that the system is working as intended.
How should companies prepare for the QMSR transition?
Preparation requires more than updating documentation or aligning terminology. Organizations should:
- Perform a gap assessment between current practices and QMSR expectations
- Evaluate how processes function not only across departments but also at the top-management level
- Strengthen integration between risk management, complaints, CAPA, and post-market surveillance
The QMSR represents a shift toward evaluating how well the system protects patients and ensures product performance, rather than just whether requirements are formally documented.
Groundhog Day 2026 was not just a date on the calendar. It was the day the FDA saw the shadow of 30 years of international practice and declared, “ISO 13485 is now part of 21 CFR Part 820.”
To go deeper, SGS offers training programs on ISO 13485 and FDA QMSR transition readiness, with a focus on practical implementation and inspection preparedness.
