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Global Medical Device Regulatory, Reimbursement, and Policy Review


Regulatory & Reimbursement

CDRH Departures and Delays, Medtech Tariffs Pushback, and More

In this week’s Pathways Picks: More scientists and reviewers are leaving FDA’s device center, and at least one prominent device lawyer says their departures have already caused tangible delays; CMS plans Parkinson’s and tremors device coverage meeting; US and Europe medtech groups align on message to zero out medtech tariffs; German insurers seek digital health reforms; and more from the US, Norway, and China.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Regulatory & Reimbursement

CDRH Departures and Delays, Medtech Tariffs Pushback, and More

In this week’s Pathways Picks: More scientists and reviewers are leaving FDA’s device center, and at least one prominent device lawyer says their departures have already caused tangible delays; CMS plans Parkinson’s and tremors device coverage meeting; US and Europe medtech groups align on message to zero out medtech tariffs; German insurers seek digital health reforms; and more from the US, Norway, and China.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review


Regulatory & Reimbursement

What’s Happening at CDRH? RIFs, Retirements, User Fees, and Unknowns

FDA’s device center lost more than 200 people in the large-scale reduction-in-force action advanced April 1, and many more have left in a steady stream of retirements and resignations under pressure by the Trump administration. Here’s a roundup of what we know about the people and functions lost at CDRH, and possible next shoes to drop, including review impacts and user-fee program risks. (Pictured: Building 66, FDA's White Oak Campus) Updated May 1

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