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FDA Official Confirms 2021 For Release Of Draft QSR, Asks For ‘Inclusive Comment Spectrum’

 
• By Shawn M. Schmitt

The US FDA’s Elizabeth Miller says the agency won’t release a draft of its revised Quality System Regulation until sometime next year. The FDA has been harmonizing its QSR with international quality systems standard ISO 13485:2016 since 2018.

QSR-ISO_193503416

A draft of the US Food and Drug Administration’s revised Quality System Regulation will be released sometime in 2021, an agency official confirmed on 17 November.

“Although delayed a bit from what was forecasted, FDA intends to publish the proposed rule for the transition of the medical device Quality System Regulation … to the ISO 13485:2016...

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