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US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

Proposed rule from US Food and Drug Administration harmonizes 21 CF Part 820 to ISO 13485 quality management system standard for medical devices.

Drawing of box with FDA logo on it

February 25, 2022

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.

FDA’s proposed rule “would harmonize quality management system requirements for FDA-regulated devices with requirements used by many other regulatory authorities around the world,” the agency states. Greater alignment of FDA Quality System Regulation (QSR) with ISO 13485, first proposed by the regulator in May 2018, 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, potentially streamlining medical device registration and compliance processes across the US and other markets.

Introducing the FDA QMSR

FDA notes that no significant efforts to revise or overhaul the QSR has been undertaken since 1996, whereas the ISO 13485 last underwent a major update in 2016. The agency’s proposed rule would amend 21 CFR Part 820 by recognizing and referencing ISO 13485:2016; once the rule is finalized, FDA’s QMS requirement will become the Quality Management System Regulation, or QMSR.

The agency finds enough similarities regarding QMS requirements between the ISO 13485:2016 standard and the FDA QSR to warrant convergence of these requirements, albeit with a few clarifications and modifications.

In terms of these clarifications and modifications, FDA has identified the following areas where 21 CFR Part 820 and ISO 13485:2016 differ enough to warrant additional requirements for US medical device market registrants:

  • QMS document controls
  • Labeling and packaging control
  • Records and recordkeeping
  • Servicing

“There are a few exceptions where we are proposing to clarify concepts or augment specific clauses of ISO 13485, but overall, we are not proposing to modify the clauses in ISO 13485,” the proposed rule states. “This philosophy also helps further regulatory convergence.”

FDA has already begun accepting ISO 13485 QMS audit reports from manufacturers under the Medical Device Single Audit Program (MDSAP), which helped inform the agency’s decision to move ahead with the proposed QMSR rule.

Higher QMS profile for risk management

Although FDA foresees adoption of ISO 13485 as less of a major QMS compliance effort for medical device manufacturers than would seem, the agency notes that ISO 13485:2016 more prominently cites risk management and risk-based decision making than does the QSR in its current iteration.

Thus, closer alignment of FDA regulations to ISO 13485:2016 means more explicit requirements for embedding risk management processes throughout manufacturers’ quality management systems, which should lead to the development of “more effective total product life-cycle risk  management systems,” according to the proposed rule.

QMSR implementation and compliance timeframes

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 prepare for full compliance.

Along with the new QMSR, FDA plans to overhaul its inspection policy known as the Quality System Inspection Technique, or QSIT. The proposed rule notes that the new inspection approach would be similar to the current QSIT, but with adjustments to reflect changes to FDA QMS regulations. However, FDA notes three key points regarding changes to inspection policy:

  • FDA inspections will not result in ISO 13485 certifications of conformity
  • FDA has no plans to develop an ISO 13485 certification program
  • Manufacturers and registrants already certified to ISO 13485 must still undergo FDA inspections for US market registration

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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