USA – Guidance : Safer Technologies Program for Medical Devices

The FDA is introducing a new, voluntary program for certain medical devices and device-led
combination products that are reasonably expected to significantly improve the safety of
currently available treatments or diagnostics that target an underlying disease or condition
associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-lifethreatening or reasonably reversible conditions. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (“De Novo request”), or premarket notification (510(k)), taking into account the specific eligibility factors described in this document. 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…