FDA takes ‘STeP’ toward safer devices

The FDA has released final guidance for a new, voluntary review process that would streamline its review of devices and device-led products designed to treat non-life-threatening diseases and make available medical treatments safer.

Modeled on the agency’s breakthrough devices program, the Safer Technologies Program (STeP) would cover devices that could improve the safety of treatments or diagnostics for underlying diseases or conditions that are less serious than those eligible for its breakthrough devices program The breakthrough program is for devices designed to treat life-threatening or irreversibly debilitating diseases or conditions. By Nancy Crotti