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The assessment bodies say they are laying off staff in the face of a decline in MDR/IVDR submissions from industry. One contributing factor, they claim, is device firms are holding off on sending full technical files until they know the outcome of pending regulatory reforms to streamline requirements.
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.
Senate Health chair loses primary and FDA AI chief departs. Excerpted from Pathways’ Picks May 21: Congress, FDA Exits, Notified Body Layoffs, CPT Codes, and More.