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US FDA formally proposes aligning Quality System Regulations with ISO 13485 – another step forward to better international harmonization

After four years the US Food and Drug Administration (US FDA) announced its willingness to align ISO 13485 Quality management system (QMS) standard and Regulation 21 CFR Part 820 (QSR), the Agency now published a highly anticipated Proposed rule to harmonize standard and regulation.

With the new version of ISO 13485 standard (ISO13485:2016), that has gained significant recognition globally outside the United States, the US FDA now finds enough similarities regarding QMS requirements between the ISO standard and the US FDA QSR to warrant convergence of these requirements, albeit with a few clarifications and modifications. Shifting to full adoption of standard 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.

In terms of clarifications and modifications, the US 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, labelling and packaging control, records and record keeping and servicing. As there is a greater emphasis on risk management activities in ISO 13485, the US FDA points out, that the Agency also expects manufacturers integrated risk management activities throughout QMS and across the total product lifecycle.

Once the final rule is published, device makers should be given one year to adapt to the new requirements. The document is open for comments for 90 days after being published in the Federal Register on 23rd of February 2022.

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

Meanwhile, the US 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.