FDA to Align with ISO 13485:2016

FDA to Align with ISO 13485:2016

The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified agenda also made it to the FDA’s Fall unified agenda published in October 2018.1 The revision will replace the existing regulation in an effort to stay modernized and harmonized with the International standard ISO 13485:2016. The revisions are intended to reduce compliance and record keeping burdens on device manufacturers by harmonizing domestic and international requirements, said the formal announcement.1

21CFR 820 is the quality system regulations followed in the US since the time it was published in 1996. The FDA QSR is based on the first edition of ISO 13485 but it has not been revised since then to adapt to the endlessly evolving medical device industry. Although there are not many differences in the FDA QSR and ISO 13485:2016, a company who wants to market their device in the US must explicitly adhere to the QSR guidelines.

This alignment initiative is another step in the direction of harmonizing regulations globally in addition to the US FDA’s participation in the Medical Device Single Audit program (MDSAP). Regulators in EU, Canada, Japan, Australia currently base their quality system requirements on ISO 13485. MDSAP too has one of its foundations based on ISO 13485:2016.

FDA has proposed the release of the new rule in April 2019. There will be a public comment period after every step before the adoption of the rule, assured William Maisel, Chief Medical Officer at FDA’s Center for Devices and Radiological Health (CDRH).2 Although a final rule may not be settled until 2020.

“FDA faces logistical challenges, including revisions to multiple agency documents that reference 21 CFR Part 820 and training FDA investigators to audit against ISO 13485:2016”, said FDA Press Officer, Stephanie Caccomo in an email to the RAPS Forum.3

An article published on the AAMI (Association for the Advancement of Medical Instrumentation) website discloses that the FDA has already completed its gap analysis between the QSR and ISO 13485:2016 and is working in collaboration with AAMI to prepare a technical information report (TIR) that cross-references the two standards to better help the industry understand the correlation between the standards.4

FDA’s adoption of the change was also welcomed by Secretary Wil Vargas of the ISO/TC 210, the ISO technical committee responsible for the quality management of medical devices. 5

How will this proposed rule affect device manufacturers?

Medical device manufacturers who are currently following the FDA QSR will have to prepare for a transition to comply with ISO 13485:2016 as well. FDA assures of a transition period to help device makers implement the change. However, the need for device manufacturers to be ISO certified remains unaddressed. Meanwhile, device makers who are already in compliance with the said ISO standard will have an easier path to market their products in the US.

Will 21CFR 820 be absorbed?

There is no clear indication of that yet. Keisha Thomas, Deputy Director of the Division of Premarket and Labeling Compliance in the FDA’s Center for Devices and Radiological Health (CDRH) explained that the ultimate goal of the agency is global harmonization and that the agency is still exploring its options. She did certainly say that there would not be dual quality management set of requirements.4

As of now, this is just a proposed rule and more concrete decisions will be available to us come Spring of 2019. Until then, we are eagerly waiting for a forthcoming report on a survey conducted by the Association for the Advancement of Medical Instrumentation (AAMI) on the feasibility and desirability of the industry for transitioning from 21 CFR 820 quality system requirements to aligning with ISO 13485:2016.

To know more about what steps you can take right now to prepare for this change, please call (248) 987-4497 or send an email to info@emmainternational.com.


1FDA (Oct 2018) Fall 2018 Unified Agenda: FDA’s New Regulatory Work to Advance Health and Safety
retrieved on 11-19-2018 from https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm623619.htm

2RAPS (Sept 2018) FDA Reveals Vision for the Transition to ISO 13485 retrieved on 11-19-2018 from https://www.raps.org/news-and-articles/news-articles/2018/9/fda-reveals-vision-for-the-transition-to-iso-13485

3RAPS (Feb 2018) FDA Considers Shift on Device Quality System Regulations retrieved on 11-19-2018 from https://www.raps.org/news-and-articles/news-articles/2018/2/fda-considers-a-shift-on-device-quality-system-reg

4AAMI (March 2018) FDA Considering Updates to Quality System Requirements retrieved on 11-19-2018 from http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=5811

5ISO (August 2018) FDA plans to use ISO 13485 for medical devices regulation retrieved on 11-19-2018 from https://www.iso.org/news/ref2318.html

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