On 2 February 2026 FDA's Quality Management System Regulation (QMSR) took effect, replacing the Quality System Regulation that device manufacturers had followed since 1997. The QMSR incorporates ISO 13485:2016 by reference and keeps a short list of FDA-specific requirements on top.
What stays the same
If your quality system is already certified to ISO 13485:2016, most of the structure carries over: management responsibility, design and development, purchasing controls, production and service, CAPA and the rest. FDA has said it will inspect against the QMSR rather than against the old QSIT approach, so expect inspections to feel more like a notified-body audit in structure.
What is different
- Terminology. Where ISO 13485 says "organisation", FDA reads "manufacturer". Several ISO terms are mapped to FDA definitions in the regulation, and your procedures should not contradict those mappings.
- Records and labelling. FDA retains requirements on record control, labelling and packaging, and on the device master record concept expressed through ISO's medical device file.
- Signature and date. FDA expects records to show who did what and when, which is stricter than some ISO-certified systems apply in practice.
- Complaint handling and MDR. Complaint files must still support Medical Device Reporting decisions; the ISO clause alone does not cover FDA's reporting obligations.
Common gaps we see
Three recur in gap assessments: management review inputs that do not include regulatory requirements explicitly; risk management that is documented for design but not for production and post-market processes; and supplier agreements that do not require notification of changes.
A practical sequence
- Run a clause-by-clause comparison of your QMS against the QMSR text, not just ISO 13485.
- Fix definitions and references in your quality manual and top-level procedures first; everything else inherits from them.
- Train internal auditors on the QMSR and run one internal audit against it before the next FDA inspection.
Vakula Tech provides quality and regulatory consultants who have worked through this transition with device and IVD manufacturers. Regulatory affairs and audit pages describe the services.