Regulatory & Reimbursement
FDA Output, May 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in May 2026. Updated May 25.
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Providers & Payors
In a Post-Inpatient Only Rule World, Tight ASC Margins, More Surgeon Choice
MS has eliminated all orthopedic procedures from the inpatient-only rule, as of January 1, 2026—part of a three-year plan to remove the list entirely--and is working on other policy changes that expand access to lower-cost ambulatory surgery centers. Experts highlight how these changes will affect manufacturers’ commercial strategies and influence ASC procurement in ways that both incentivize and discourage adoption of high-cost technologies.
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Pathways’ Pick of the Week
Pathways Pick of the Week: Happy EUDAMED Day
The first EUDAMED registration requirements took effect on May 28. Excerpted from Pathways’ Picks May 27: EU Milestones, Medtech Pilot Programs, FDA Biocomp Recognition.