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See today's BioWorld MedTech
Home » Shuren floats voluntary alternative pathway for digital device premarket review
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2022 Medtech Conference

Shuren floats voluntary alternative pathway for digital device premarket review

Oct. 27, 2022
By Mark McCarty
Innovative medical devices are the norm for reviewers at the U.S. FDA’s Center for Devices and Radiological Health (CDRH), but regulatory innovation is a tougher climb. In response, CDRH director Jeff Shuren said at this year’s Medtech Conference in Boston that the agency is eyeing a voluntary alternative pathway (VAP) for novel digital technologies, although this concept is unlikely to see the regulatory light of day other than as a pilot program at any point in the next year or two, given the need for statutory authorization.
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