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

 
• 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.

QSR-ISO_193503416

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

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