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# Medical Device Safer Technologies Program Guidance
- URL: https://www.fdaweb.com/medical-device-safer-technologies-program-guidance/
- Published: 2021-01-05T12:00:00.000Z
- Updated: 2026-09-14T16:41:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148371

FDA has published a guidance, *Safer Technologies Program for Medical Devices*, to introduce 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 Device Program. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the agency believes the Safer Technologies Program (STeP) will help patients have more timely access to the 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 guidance includes Introduction, Background, Program Principles, Factors for STeP Entrance and Review Process, Mechanisms for Feedback on Development of Devices in STeP, and an appendix with an example of recommended contents of a Q-Submission request for inclusion in STeP.