The Association for the Advancement of Medical Instrumentation (AAMI) has now published AAMI TIR102:2019, which maps the US Food and Drug Administration (FDA) Quality System Regulation (QSR, 21 CFR 820) to ISO 13485:2016 and vice versa.
The abstract for the Technical Information Report (TIR) reads: “This document provides a mapping of the US FDA 21 CFR requirements to the ‘regulatory requirements’ references in ISO 3485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.”
The scope of the TIR reads:
“This document is a comparison of requirements between 21 CFR 820 and ANSI/AAMI/ISO 13485:2016 that demonstrates similarities, highlights differences, and discusses key considerations for medical device manufacturers. It is not a word-for-word literal identification of differences; thus, the reader must be familiar with quality management system requirements along with the statutory definitions to apply this report.
This document provides the basis for interpretation of the associated requirements and applicable U.S. FDA rules. Users must be aware that this analysis provides a comparison of the QS Regulation and the standard only. It is not inclusive of all global regulatory requirements applicable to medical device quality systems.
The comparison covers all parts of 21 CFR 820 including appropriate references to the Preamble to the QS Regulation and ANSI/AAMI/ISO 13485:2016. Other standards or parts of the U.S. regulations may be referenced but are not explicitly included in this report.”
Copies of the TIR may be purchased from the AAMI website.