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US FDA Issues Quality Management System Amendment FAQs

US FDA has provided answers to Frequently Asked Questions regarding planned harmonization of 21 CFR Part 820 quality management system requirements with the ISO 13485 standard.

Person taking notes on a clipboard while someone tests a medical device

March 10, 2022

As we previously reported, the US Food and Drug Administration has published a highly anticipated proposed rule to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard.

To recap, greater alignment of FDA Quality System Regulation (QSR) with ISO 13485 would bring US QMS requirements for medical device manufacturers closer in line with quality system requirements in markets such as the European Union, Japan and Australia. The proposed amendment’s intent is to streamline medical device registration and compliance processes in the US, harmonizing them with other markets. For medical device manufacturers seeking registration in the US and other markets, the proposed amendment could mean more efficiency and lower compliance costs.

FAQs about the proposed QSR amendment

Now, to help medical device manufacturers better understand how this harmonization of the US regulation and the international standard may help make medical device approval in multiple markets more efficient, the FDA has issued its responses to these frequently asked questions.

The FDA’s answers to its seven most highly anticipated questions cover:

  • Why the FDA is proposing this harmonized amendment.
  • What the difference is between ISO 13485 and the current 21 CFR Part 820.
  • What the FDA is doing to prepare for harmonization of the Quality System Regulation with ISO 13485.
  • What training will the FDA staff do if the amendment is finalized?
  • How will this rule impact FDA staff and programs if the amendment is finalized?
  • Will there be a new inspection technique if the amendment is finalized?

The FDA answers should provide welcome information to medical device manufacturers who want to better understand the proposed improvements to the medical device registration process in the US. These proposed changes would be particularly helpful to multinational medical device manufacturers when seeking regulatory clearance in the US and other markets.

QMSR implementation and compliance timeframes

As previously reported, FDA will accept comments on its proposed QSMR rule from industry and stakeholders through May 24, 2022. Once the agency publishes a final version of the rule in the Federal Register, US medical device market registrants will have one year to achieve full compliance.

Emergo by UL will provide additional reporting on these significant changes to FDA QMS regulations in the coming weeks.

Additional medical device QMS compliance resources from Emergo by UL:


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