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With MDCG guidance on change control promised by year’s end, notified bodies and experts weigh in on how much latitude device and digital health firms should have in making product modifications, and where PCCPs fit in. Europe could offer more room than the US for continuous innovation—if it can settle on which changes need notified body approval.
In September, a high-profile FDA advisory committee panel recommended regulatory approval of GRAIL’s multi-cancer early detection screening test, paving the way for a new paradigm in diagnostics. Wall Street and companies working on MCEDs responded favorably, and GRAIL’s stock jumped. The panel opinion has nuances, however, and the next steps will be critical in sorting out an opportunity that is guaranteed to be complicated, as well as exciting.
Medtech groups formally respond to CMS’ RAPID proposal for regulatory-reimbursement alignment. Excerpted from Pathways Picks October 14: RAPID Response, Notified Body Needs, CDRH Retirement, and More.