ARTICLE SUMMARY:
In this week’s Pathways Picks: The US Quality Management System Regulation takes effect, launching a new framework for FDA inspections and triggering other updates; the EU harmonizes more medtech standards; South Korea spotlights “innovative device” designations; India drafts another IVD guide; US funding bill extends telehealth payments; and more.
A New Chapter for Inspections
FDA’s Quality Management System Regulation era begins:
QMSR ascends. A new era of FDA inspections kicked off February 2. That’s the day the agency’s new Quality Management System Regulation took full effect, replacing the legacy Quality System Regulation. In conjunction, FDA retired its well-worn Quality System Inspection Technique (QSIT) and published a new compliance program manual to lay out expectations for FDA investigators under the QMSR. The new regulation aligns FDA with the global ISO 13485 standard, with exceptions needed to comply with US law. That doesn’t necessarily mean there will be wholesale changes in what investigators will be looking for, as there was already significant overlap with ISO 13485. There will certainly be new focus by the agency on how companies document management’s review of their systems and internal audits of their own facilities and suppliers’ facilities. Those are areas that were exempt from scrutiny under the QSR but are within-scope of the QMSR. “Such records are maintained in the regular course of business and should be readily available upon inspection,” FDA states on an FAQ site for the new regulation.
