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CDRH Preps New Program To Streamline Approval-To-Reimbursement Path

The device center is in the very early stages of launching the “CDRH Reimbursement Program,” planning to go beyond its current parallel-review collaboration with CMS to work with device firms, CMS and private payers to streamline the pathway from market approval to reimbursement.

FDA’s device center is expanding on its efforts to facilitate a device firm’s path from market approval to gaining reimbursement with the nascent “CDRH Reimbursement Program.”

Murray Sheldon, CDRH’s associate director for technology and innovation, unveiled the program Dec. 19 at the American Gastroenterological Association/FDA Regulation and Reimbursement Workshop in Washington, D.C

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