‘STeP’ By ‘STeP’: FDA Finalizes Accelerated Pathway For Novel Devices, Combo Products

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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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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