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.
The US FDA’s decision to allow Medtronic to market the Symplicity Spyral renal denervation (RDN) device sets up a rivalry in the RDN market, as the medtech giant’s offering will come up against ReCor’s Paradise system.
News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope
This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.