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As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR

 
• By Shawn M. Schmitt

The US FDA’s internal deadline of October 2020 for putting out a draft of its retooled Quality System Regulation is the fourth it failed to meet. The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

FDA entrance sign 2016

Unsurprisingly, the US Food and Drug Administration has missed its fourth consecutive internal deadline for releasing a draft of its retooled Quality System Regulation.

The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

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