Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program
Manufacturers applying to the program should be ready for questions from the US agency, an FDA official says.
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The US FDA released a final guidance document on 5 January that sets in place its new voluntary Safer Technologies Program, or STeP. Modeled after the agency’s burgeoning Breakthrough Devices Program, STeP is for innovative devices and device-led combo products heading for a PMA, 510(k) or de novo regulatory route that aim to treat less serious conditions than devices accepted into the Breakthrough program.
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