Скачать или смотреть Guidance on CMS Medical Device Coverage Determination

In this episode of FDA Clinical Insights, NAMSA brings together leading experts Dorothy Abel, Dr. Robert E. Lee, Dr. Adam E. Saltman, and Chris Mullin to explore the factors that influence CMS coverage of medical devices. Dr. Saltman discusses why the average delay between regulatory authorization and reimbursement coverage can extend for years, and how that impacts medical technology developers preparing to enter the market.

The discussion emphasizes the importance of early alignment between regulatory and reimbursement strategies. By considering CMS coverage determination guidance alongside FDA requirements, manufacturers can better position their devices for faster access and long-term success.