‘STeP’ By ‘STeP’: FDA Finalizes Accelerated Pathway For Novel Devices, Combo Products
• By Shawn M. Schmitt
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 Food and Drug Administration is putting the finishing touches on a new voluntary pathway that aims to bring innovative, novel medical devices and device-led combination products to patients more quickly.
The FDA says in a final guidance document dated 6 January that it will stand up its Safer Technologies...
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The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
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The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.