The FDA issued final guidance on a new voluntary program being introduced for medical devices that are not quite eligible for the Breakthrough Devices Program. Devices eligible for the “STeP” program may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions.

According to a press release, “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.” 

FDA says it has modeled STeP on the principles and features of its Breakthrough Devices Program, and plans to similarly provide interactive and timely communications, early engagement on Data Development Plans (DDPs), sprint discussions, and senior management engagement.

For more information, you can download the final guidance document