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...