Industry To FDA: 1 Year Isn’t Enough Time To Transition To New QMSR Rule
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.
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The makers of breathing machines said in comments to the US agency that it must address language in its draft Quality Management System Regulation that the companies say would place onerous traceability requirements on most medical devices.
Jeff Shuren, director of the US FDA’s device center, said on 4 May that the agency “thought it was enough time” when it proposed a one-year transition time frame from its current Quality System Regulation to the new Quality Management System Regulation.
Steve Silverman, a former compliance director for the US FDA’s device center, gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation.