It’s Time for The FDA to Fully Embrace ISO 13485

FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to work in tandem with ISO 13485:1996. The purpose was to alleviate some of the burden on medical device manufacturers who had to meet two different standards: the FDA regulation and ISO 13485.

Yet in 2003, ISO 13485 was changed so significantly that the FDA QSR was no longer aligned with it. Now the FDA wants to update the QSR to bring it in line with ISO 13485:2016. But will this solve the problem? Can the FDA and the industry use the new QSR cooperatively?

In this article, Grant Ramaley explains the need for the FDA to adopt ISO 13485 certification to comply with regulations governing quality system management for medical device manufacturers.