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FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation

 
• By Shawn M. Schmitt

February 2021 is the latest target date selected by the US agency for releasing a draft of its retooled QSR, which has been undergoing a facelift for more than two years to harmonize it with international quality systems standard ISO 13485.

3D illustration of number 2021 with target.

The US Food and Drug Administration has selected February 2021 as the latest target date for releasing a draft of its retooled Quality System Regulation, which has been undergoing a facelift since early 2018.

This is the fifth in-house deadline the FDA has set for issuing its draft rule, which will harmonize the QSR with international quality systems standard ISO 13485:2016. The agency had previously set deadlines of April 2019, September 2019,

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