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Philips, Hamilton Medical To FDA: QMSR Shouldn’t Subject Devices To ISO Traceability Requirements

 
• By Shawn M. Schmitt

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.

3D-modeled interlinked nodes, amongst whom a pathway is highlighted, representing traceability.
• Source: Shutterstock

Two makers of breathing machines have told the US Food and Drug Administration that it must address language in its draft Quality Management System Regulation (QMSR) that the manufacturers say would place onerous traceability requirements on most medical devices.

24 May is the deadline for commenting on the proposed QMSR, which will replace the FDA’s Quality System Regulation. The QSR has been the bedrock rule for making safe...

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