FDA final rule will align it more closely with ISO 13485:2016

On January 31, 2024, the FDA issued a final rule (Medical Devices; Quality System Regulation Amendments) which was published on 2 February 2024 and will become effective on 2 February 2026.

Why was the final rule issued?

The final rule was issued to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation under 21 CFR 820 to harmonize and modernize the regulation.

The harmonization is to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements for medical devices used by many other regulatory authorities around the world.

How is the harmonisation achieved?

This rule:

  • amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems (QMS) set by the International Organization for Standardization (ISO), ISO 13485:2016. The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act.  
  • amends the title of the regulation and establishes additional requirements that clarify certain expectations and certain concepts used in ISO 13485.  These additions ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements.

The FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products.  These edits do not impact the CGMP requirements for combination products. 

Essentially, the FDA is amending the title of the regulation, and establishing requirements and provisions that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to as the Quality Management System Regulation (QMSR).

Note: When referring to the rule that is currently effective, the FDA uses the term “Quality System (QS) Regulation” or “QS regulation.” Because both the QMSR and the QS regulation are located in part 820, wherever possible, the FDA has used the terms “QS regulation” and “QMSR.”

Does this mean that there will be a new FDA inspection process?

Yes, the FDA will develop a new inspection process to align with the requirements of the new Quality Management System Regulation (QMSR).  The process will be developed for implementation when the rule takes effect (i.e. on 2 February 2026).

Now that FDA has incorporated ISO 13485:2016, what happens if the standard is revised?

Any future revisions to this standard would need to be evaluated to determine the impact of the changes and whether the QMSR should be amended.   If needed, amendments to the QMSR will be implemented through rulemaking.

When will the new regulation be effective?   

The rule is effective two years after publication in the Federal Register i.e. from 2 February 2026. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date.

Source: FDA

Further reading

1. FDA issues QMSR final rule with 2-year transition period – 31 January 2024, RAPS

2. FDA issues final rule to more closely align with ISO 13485– By Mahnu Davar & et al,  February 8, 2024, Arnold & Porter

3. Harmony and Me: FDA Issues Final Rule to Amend Quality System Regulation for Medical Devices – By Arnall Golden Gregory LLP, 13 February 2024, JDSupra

4. FDA’s new Quality Management System Regulation is here: Key takeaways for device companies in US, EU, and China – By Bethany Hills et al, 16 February 2024, DLA Piper