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

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 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