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FDA publishes final rule to harmonize quality system requirements with global standard

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Dive Brief:

  • The Food and Drug Administration published a final rule Wednesday to harmonize aspects of quality management system (QMS) requirements with the international standard.
  • Officials finalized the text after reviewing feedback on the 2022 proposed rule. The FDA said almost all respondents supported the goal of updating and modernizing the current good manufacturing practice (cGMP) requirements by incorporating ISO 13485. 
  • Acting on points raised in the consultation, the agency has made changes to the proposed rule, “primarily for clarity and accuracy and to improve understanding of the requirements of the [QMS regulation],” and extended the transition timeline from one to two years.

Dive Insight:

The FDA outlined plans to move to ISO 13485, an international document that specifies requirements for a QMS, in 2018. The goal was to “reduce compliance and recordkeeping burdens” on manufacturers. FDA officials shared a proposed rule almost two years ago that outlined what the changes would mean in practice.  

Now, the agency has finalized the rule. In a statement, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the agency’s rule is “streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities” by harmonizing “key areas” of the QMS with the international standard.

The original proposals were well received in 2022, with Advamed telling the FDA it “strongly” supports more closely aligning the cGMP requirements of the Quality System Regulation with the international consensus standard. Based on the feedback, the FDA has retained the core focus of the rule while making some changes to address requests for clarification. 

FDA officials responded to 83 comments to explain either the changes the agency made in light of the feedback or why it disagrees with the observations. The date the rule takes effect is one point that respondents managed to get changed. 

Originally, the FDA proposed a one-year transition but respondents explained that “would not be enough time to train staff, revise processes and/or procedures, and make necessary changes to current practices.” The FDA agreed, leading it to give companies an extra year to prepare. The rule will now take effect on Feb. 2, 2026.

Officials also changed the rule in response to the “many comments” that recommended revising proposed definitions for specific terms. The FDA adopted the ISO 9000 definitions for terms such as “customer,” “nonconformity” and “verification.”

Nick Paul Taylor

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