FDA's Quality Management System Regulation replaces the Quality System Regulation in 21 CFR Part 820 by incorporating ISO 13485 by reference, effective February 2, 2026. For most manufacturers already certified to ISO 13485 the change is one of terminology, documentation mapping and record expectations rather than a wholesale system rebuild.
What actually changes
The regulatory text changes more than the day-to-day work does. ISO 13485 is incorporated by reference, with FDA-specific requirements retained for areas such as labeling, packaging and record availability, and definitions aligned to the standard.
The practical work is mapping: your existing procedures, forms and training refer to QSR clause numbers and QSR vocabulary. Those references have to be located and corrected everywhere they appear, including in documents nobody has opened in three years.
Where firms underestimate the effort
- Terminology alignment across the whole document set, not only the quality manual
- Risk-based thinking expected throughout the system rather than confined to design risk files
- Management review inputs and outputs restated against the standard's expectations
- Supplier controls and purchasing information evidence
- Training records that reference superseded clause numbers
A sensible sequence
Start with a gap assessment against the incorporated standard, then fix the quality manual and the top-level procedures, then cascade to forms and work instructions. Leave the training refresh until the documents are stable so people are trained once.
Firms that are not currently certified to ISO 13485 have more work, particularly around documented processes and risk management, and should plan for a longer runway.
Reviewed by the named consultant. Last updated July 14, 2026. General information only — not regulatory or legal advice for a specific situation.