ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA issues draft guide on addressing new quality system framework in premarket submissions, and removes atypical warning letters; Medicare coverage determinations unleashed; EU AI Act faces reforms prospects and standards challenges; South Korea’s regulatory agency issues guides on assessing device trial safety events and on its procedures for publicly disclosing companies’ product information.
US Picks
FDA and CMS updates:
Quality gap analysis needed for FDA submissions. Companies planning to submit PMAs or humanitarian device exemptions soon with FDA reviews that are likely to go past February 2, 2026, when FDA’s new Quality Management System Regulation (QMSR) takes effect, should prepare gap analyses to help FDA properly vet the quality information in the submission. That message was delivered in a draft guidance published by FDA October 28 outlining quality management information companies will need to include in submissions to comply with the new regulations, which will replace FDA’s longstanding Quality System Regulation to more fully harmonize with the global ISO 13485:2016 standard. The guide makes clear that, once February 2 hits, FDA will be evaluating all submission records to affirm compliance with the new QMSR, but it also recognizes that it will need to consider how to manage submissions as least partially received prior to February 2 but still under review after that date. “A gap analysis or another type of comparative analysis may assist FDA in determining when documents and records created prior to the QMSR effective date are submitted to FDA,” the draft states. A similar analysis will also aid FDA in properly conducting PMA preapproval inspections for pre-February 2 submissions, the document notes. The guide, when finalized, will replace a 22-year-old document that explains how to demonstrate compliance with the expiring QSR. FDA issued the draft unofficially, without a comment period, in the context of the ongoing government shutdown. “After the lapse in appropriations ends, a notice of availability for the guidance will be published in the Federal Register, which will detail how to submit comments on this document,” the agency writes.
