21 CFR 820 and ISO 13485:2016 Harmonization: Getting
Ready for the QMSR
1.0 Purpose
The purpose of this document is to provide recommendations for the transition of 21 CFR 820 to
harmonization with ISO 13485:2016. This document is intended for current users of 21 CFR 820, those
who will require adaptation to ISO 13485:2016, as well as other interested parties. These parties
include, but are not limited to, medical device manufacturers, accreditation bodies, certification
bodies, registrars, and regulatory authorities that include the use of 21 CFR 820.
2.0 Introduction
FDA guidance of QSR (Quality System Regulation) 21 CFR 820 was developed in 1978 to discuss current
good manufacturing practices for medical devices. Since its development, the guidance has been
updated two times to include further CGMP guidance and consideration of ISO 9001:1994. In 2022,
the FDA has proposed harmonization of QSR 21 CFR 820 and the international standard ISO
13485:2016. The ISO 13485:2016 standard is based on ISO 9001:2008 discussing design and
manufacturing of medical devices.
3.0 Explanation
The FDA has suggested updating QSR 21 CFR 820 to simply quality systems of medical device
companies. The suggestion comes after the FDA has reviewed ISO 13485:2016 and identified many
similarities between both QSR and ISO 13485. The FDA is hoping to ease the regulatory burden of US
medical device companies and improve the capability of international trade.
Many of the suggested changes are requiring the medical device companies to keep better history of
finished medical devices, as well as medical device parts, which will be used with the finished medical
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devices. This update will require companies to have a Quality Management System (QMS) which is
compliant with QSR and ISO regulations.
Other changes set a precedence for the FDA’s focus on global harmonization and increased safety
measures. Definitions have been updated to stress a culture of quality and streamline both regulations
to simplify compliance and interpretation. Device record keeping is also emphasized in the proposal
to highlight the importance of traceability for the patient if adverse effects did occur.
The FDA understands that this update will impact smaller medical device companies in the United
States specifically and discusses that although the changes may be difficult at first, they will lead to
the possibility of global expansion for these manufacturers.
4.0 Transition
The FDA is proposing a one-year timeframe after the final rule for the transition into alignment of 21
CFR 820 and ISO 13485. Although this is still a proposal timeframe, company hesitation or
procrastination is not warranted. The proposed changes will require medical device manufacturers
to update procedures and possibly validate new procedures to comply.
©PathWise 2022
About the Author: Faith Wall is has been working in Life Science regulated industries for 7 years. She has developed and implemented global
training of instrumentation documentation, cGMP and FDA requirements, and scientific programs. Faith has extensive experience in
documentation, including deviations, investigations, change controls, and CAPA. As a quality system trainer, Faith focuses on a quality mindset,
with a focus on product impact and patient safety.
Compliant. Effective. Efficient. 1-866-580-PATH www.pathwise.com
