The FDA is striving to harmonize its regulatory framework with that of other regulatory bodies, aiming to be consistent in device regulation. This alignment seeks to expedite the introduction of safe, effective, and top-quality devices for patients.

Through the implementation of this rule, changes to the title of the regulation and addition of new requirements to explain certain expectations and concepts from ISO 13485 were made. These changes make sure that using ISO 13485 doesn't cause any conflicts with other FDA rules.

The updated section 820 is now called the Quality Management System Regulation (QMSR). FDA also revised the section to clarify the Quality Management System (QMS) requirements for combination products in part 4 (21 CFR part 4), but this doesn't affect the rules about how combination products are made.

The following questions below are the Frequently Asked Questions related to this rule

Q: Why is the FDA taking this action?

Q: What is the FDA doing to prepare for harmonization of the Quality System regulation with ISO 13485?

Q: What training will FDA staff do?

Q: How will this rule impact FDA staff and programs?

Q: Will there be a new inspection process?

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

Q. When will the new regulation be effective?

The answers to the questions above are available on the FAQ answers link.




Quality Management System Regulation: Final Rule Amending the Quality System Regulation