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

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.