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  • Sarah Nixon & Aditi Pillai

FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?

Updated: Mar 11


The FDA has announced that their current quality system regulation will be replaced by one incorporating references to ISO 13485:2016. This is a major change in the medical device quality and regulatory world, as the current FDA QSR (21 CFR Part 820) has been in effect since 1996. The new, combined regulations will be known as the QMSR. We expect the QMSR to become effective in summer 2023. This announcement marks a large step forward in the push for global convergence of medical device regulatory processes. The FDA has long supported ISO 13485, including significant participation in its latest revision.


Harmonization with the internationally adopted ISO 13485:2016 will reduce the burden of duplicating compliance efforts currently imposed on device manufacturers. By removing these redundancies, the FDA hopes to increase market access and remove barriers to patient access and costs. In addition to the reduced record keeping, the harmonization will make US companies more prepared to enter international markets.


What it means for a startup


This news will sound especially appealing to medical device startups whose regulatory plan may not fully be determined. Creating a QMS compliant with ISO 13485:2016 will lead to a more globally harmonized QMS, and allow for less burdensome regulatory pivots. ISO 13485:2016 expands QMS principles into more aspects of medical device development than the previous FDA quality system regulation, providing more structure for successful development. The increased guidance available leaves less guesswork to those new to QMS development and implementation. ISO 13485:2016 incorporates risk management principles from ISO 14971, aiding a startup in developing safe and effective medical devices from the beginning, and reducing the time and money spent on reiterations when risks are identified further along. Additionally, if your QMS is designed only for FDA QSR, you will need significant updates to include ISO 13485:2016 and comply with the QMSR.


Immediate steps to take


Now is the time for medical device companies to identify and rectify ISO 13485:2016 gaps in their QMS. The FDA has noted that the current part 820 requirements are “substantially similar” to the requirements of ISO 13485; however, these proposed updates will include additional definitions, clarification of concepts, and added requirements. The RookQS team is experienced in implementing ISO 13485:2016 quality systems for all types of medical device companies- including SaMD and diagnostics- and can help your team get moving. RookQS' 11 Certified Auditors can perform gap assessments or internal audits for companies at all levels of QMS development. We're also here to support you in closing out any gaps identified. It's never too early (or too late) to work towards compliance!


For more insights on the FDA ISO harmonization, here is a recording of our webinar from 3/10 presented by Rook regulatory experts Kyle Rose and Sarah Nixon!



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