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Updated March 4, 2021
FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg - Medtech Insight
--- original post follows below ---
According to the article:
"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. ...
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, April 2020 and October 2020."
Read the full article: FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight
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