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CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role

In an interview, CDRH Director Jeffrey Shuren detailed plans for new guidance documents and process changes at the device center focused on IDE reviews, clinical testing requirements and pre-submission interactions with payers based on recommendations from the center’s entrepreneurs-in-residence program.

FDA plans to implement new guidance documents and process changes over the next year in response to suggestions from CDRH’s entrepreneurs-in-residence program, CDRH Director Jeffrey Shuren told “The Gray Sheet.”

In the entrepreneurs-in-residence program, CDRH organized teams of outside experts from industry, government and academia to work with agency staffers on projects to improve the center’s capabilities and help bring...

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