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. The revision will replace the existing regulation in an effort to stay modernized and harmonized with the International standard ISO 13485:2016...

1. FDA to Align with ISO 13485:2016
By: Nikita Angane, MS
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.i 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 recordkeeping burdens on device manufacturers by harmonizing
domestic and international requirements, said the formal announcement.i
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).ii 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.iii
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.iv
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.v
How will this proposed rule affect device manufacturers?

2. Page 2 of 3
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.iv
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.
i
FDA (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
ii
RAPS (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
iii
RAPS (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
iv
AAMI (March 2018) FDA Considering Updates to Quality System Requirements retrieved on
11-19-2018 from http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=5811

3. Page 3 of 3
v
ISO (August 2018) FDAplans to useISO 13485 formedicaldevices regulation retrieved on11-19-2018
fromhttps://www.iso.org/news/ref2318.html