Medical Device Companies Take Note: FDA’s Proposed Rule to Align ISO 13485 With its Quality System Regulation Moves Forward

On January 5, 2022, the U.S. Office of Management and Budget (OMB) received the long-awaited proposed rule from the Food and Drug Administration (FDA) that aims to harmonize FDA’s medical device Quality System Regulation (QSR) under 21 CFR Part 820 with International Organization for Standardization (ISO) 13485, the international standard for medical device quality management systems.¹

OMB sits within the Executive Office of the President, and it routinely receives and reviews proposed and final regulations from government agencies in line with Executive Order 12866. While the review of this proposed rule is likely to take some time, it is anticipated that FDA will be able to publish it following OMB’s review. 

A brief history
 
Many regulatory authorities around the world use ISO 13485:2016 as a basis for quality management system requirements. Since 2018, FDA has been working to align its quality system regulation (QSR) for medical devices with ISO 13485, with the goals of reducing burdens on medical device companies with global products that face different international regulations and updating its quality system requirements. According to the abstract available on OMB’s website, “[t]he revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”² 

Additionally, FDA plans to leverage the Medical Device Single Audit Program (MDSAP) in its efforts to adopt the ISO standard as these audits are already conducted against ISO 13485. MDSAP “allows a MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the various regulatory authorities participating in the program.”³ Indeed, FDA stated that it plans to use MDSAP as it fully incorporates ISO 13485.

What’s next?

We expect that OMB’s review may take some time. OMB has 90 days to review proposed rules, but this can be extended. If FDA publishes the proposed rule, we anticipate that FDA will need to work through a significant number of comments submitted by industry and the public before finalizing the rule.

Once the rule is finalized, it likely will affect many of FDA’s existing policies and procedures. FDA has stated in press releases and public comments that it recognizes the significant impact this regulatory transition will have. For example, there may need to be

• training on ISO 13485 requirements, interpretation, best practices, etc. to Center for Devices and Radiological Health staff and Office of Regulatory Affairs investigators and compliance officers
• changes to the FDA inspection model
• revisions/updates to numerous documents
• changes to IT systems⁴

How can companies prepare?

To help assist with the transition, companies should consider taking a number of steps, including

• performing a comparison to assess the differences between ISO 13485 and the QSR 
• evaluating the benefits of ISO certification prior to promulgation of FDA’s final rule
• considering ISO 13485 and terminology when updating procedures and policies

The good news is that FDA has finally sent its draft regulations to OMB, which brings the harmonization efforts a step closer to fruition. But there will be a lengthy transition period. Companies should consider taking steps now to assess any gaps they may have and develop plans to ensure a smooth transition for when FDA’s new regulations become effective. 

¹ https://www.reginfo.gov/public/do/eoDetails?rrid=212912
² https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0910-AH99
³ https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap
⁴ https://www.fda.gov/media/123488/download