CDRH's Innovation Pathway: A Quicker Route For Breakthrough Devices?
This article was originally published in The Gray Sheet
Executive SummaryFor a select few devices per year, FDA says it will speed up pre-market development times by intensifying staff efforts, with a particular focus on very early-stage, frequent interactions with product sponsors.
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CDRH Director Jeffrey Shuren participated in the first roundtable of a newly launched House Energy and Commerce Committee initiative to accelerate drug and device development. He emphasized the device center’s recent proposals to minimize pre-market data collection with postmarket controls, and supported the promise of clinical trial networks.
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.
Device center officials cite a host of formal and informal actions available under existing legislative authority to ensure that development and review of companion diagnostics do not hinder the ability of FDA-designated breakthrough therapies from coming to market.