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Industry To FDA: 1 Year Isn’t Enough Time To Transition To New QMSR Rule

 
• By Shawn M. Schmitt

Stakeholders and industry groups at a 2 March US FDA panel meeting said two years, not one, will be needed for device makers to comply with the agency’s proposed Quality Management System Regulation, which when finalized will replace the current Quality System Regulation.

A close-up of a sand clock on a teal blue background.
• Source: Alamy

Medtech industry groups and other stakeholders told the US Food and Drug Administration on 2 March that one year simply isn’t enough time for device makers to transition to the agency’s proposed Quality Management System Regulation.

The QMSR was released as a draft rule on 22 February. When finalized, it will replace the FDA’s Quality System Regulation, which has been the bedrock rule for making safe and effective devices in the US since the mid-1990s. The QMSR is a result of the agency’s years-long work harmonizing the QSR with international quality systems standard ISO 13485:2016. (

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