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Christmas Is Coming, But Will There Be International Harmonization?

 
• By Brian Bossetta

Since the US FDA released a proposed rule for its new Quality Management System Regulation in February 2022, the agency has been steadfast that it would publish the final rule before the close of 2023 despite much skepticism. Now with that deadline fast approaching, will the agency prove skeptics wrong?

On The Same Page
• Source: Shutterstock

For some time now, the Food and Drug Administration has been looking to mesh its Quality System Regulation (QSR) with international standards for medical device quality management systems.

Specifically, the agency plans to replace QSR with a new document, the Quality Management System Regulation, or QMSR, which will marry FDA quality regulations to the 2016 version of ISO...

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