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.
These devices should improve on existing diagnostics’ or treatments’ safety by reducing adverse events, device failures, use-related hazards or user errors or by improving the safety of other devices or interventions.
The FDA and the medtech industry have come under fire in the past few years following highly critical investigative reports by journalists and documentarians. The critiques spurred the agency to improve its efforts at device safety.
Like the breakthrough device program, STeP would expedite the development, assessment and review of these devices, including interactive and timely communications with the agency, early engagement on data development plans, prioritized review and senior management engagement.
“Consistent with the agency’s statutory mission to protect and promote public health, FDA believes that this ‘Safer Technologies Program’ or ‘STeP’ will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance,” the agency said in a news release.
You can read the final guidance here.