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Medcon 2023: FDA Hopes To Release Final QMSR By Year’s End

 
• By Elizabeth Orr

The destination may be in sight for the long trip that’s been the US agency’s quality systems rewrite. Regulators speaking at Medcon 2023 said December remains the goal for publication.

Aaron Dunbar, Keisha Thomas and Karen Masley-Joseph speak at the Medcon podium, 26 April 2023
Olympus VP Aaron Dunbar and FDAers Keisha Thomas and Karen Masley-Joseph speak at Medcon on 26 April. • Source: Elizabeth Orr/Medtech Insight

It’s been a long 14 months since the US Food and Drug Administration released a draft Quality Management System Regulation (QMSR) in February 2022, and the wait is not over quite yet.

Officials hope to finalize the rewrite of the country’s bedrock medical device regulations by the end of December, Keisha Thomas,...

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