News

US market access : the FDA may replace QSR with ISO 13485:2016

The Food and Drug Administration  is considering replacing their actual Quality System Requirements (QSR) from 21CFR part 820 with the requirements from ISO 13485 version 2016. This is for the moment a proposition of rule modification, which should be decided within a year.

We can only salute this project, as the gap between QSR and ISO13485:2016 are thin but nonetheless significant to complicate the access to US market.

In anticipation of difficulties and confusion that the European Regulation 2017/745 will bring, this measure from the FDA may increase even more the attractiveness of north-american market : we can only expect regulatory complications in Europe while simplifications are on their way on the other side of the Atlantic !