By 2020, the Food and Drug Administration (FDA) is planning to change its quality system requirements for medical device manufacturers stipulated in 21 CFR 820 by ISO 13485 :2016.

This decision was taken as more and more regulators are looking toward adopting globally harmonized requirements that utilize regulations as well as standards, such as ISO 13485:2016. Additionally, there are many similarities between the requirements of the Quality System Regulation and the clauses of 13485:2016, especially in terms of regulatory requirements.

The FDA has already performed an initial gap analysis between the Quality System Regulation (21 CFR 820) and ISO 13485:2016 and is planning to develop a technical information report (TIR) that will cross reference 21 CFR 820 with ISO 13485:2016 and vice versa. The TIR will help companies to understand the correlation of the regulation to the standard and the benefits of using 13485 as the basis for the quality management system requirements.

FDA is planning to have a transition period to allow manufacturers to fully implement ISO 13485:2016.

To better understand the differences between QSR requirements and ISO13485:2016 requirements, email us at and check our checklist here attached.

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