Delayed Twice, FDA Now Says It Won’t Release Its Harmonized QSR/ISO 13485 Draft Rule Until April 2020

20 Nov 2019

• By Shawn M. Schmitt

First it was April 2019, then September 2019 – but both of those deadlines were missed. Now, the US agency has set a target date of April 2020 to release a draft regulation that will harmonize its Quality System Regulation (QSR) with international standard ISO 13485.

The US Food and Drug Administration has once again pushed back its deadline for delivering a draft version of a new rule that will harmonize its Quality System Regulation (QSR) with international standard ISO 13485.

The agency has updated its official regulatory agenda to note that the draft regulation won’t be ready until April...