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Planned PMA Pathway Modeled On Existing Accelerated Programs

CDRH’s plans for a specialized pathway for high-risk PMA devices that address unmet medical needs will be modeled on the drug center’s recently established breakthrough therapy pathway, and also the device center’s Innovation Pathway.

The newly planned accelerated PMA pathway for high-risk medical devices that address unmet medical needs will be modeled off of the Center for Drug Evaluation and Research’s breakthrough therapies accelerated pathway, as well as the device center’s Innovation Pathway, according to CDRH Director Jeffrey Shuren.

The CDER breakthrough drug therapy pathway was mandated by the FDA Safety and Innovation Act in 2012. CDER can designate breakthrough status to an investigational drug that shows dramatic improvement...

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