Pathways’ Picks’ August 4: FDA on Intended Use, CMS on New Tech, and More to Watch

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In this week’s roundup: FDA drops a final regulation parsing its policies for determining a product’s “intended use;” CMS issues the final inpatient reimbursement rule, setting a high bar for non-Breakthrough new-tech add-on payments; FDA unveils device shortage reporting tools and discloses user fee hikes; study scrutinizes adverse event reports of death; Europe issues COVID-19 test guide; and CMS publishes innovation report.

Editors’ Note: There will be no Pathways’ Picks next week, on August 11. Follow us online at Market Pathways, and look out for the next Picks on August 18.

Top picks this week are FDA’s intended use rule, released after years of battle, and CMS’ hospital inpatient payment rule. That and much more in Pathways’ Picks.


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