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# CDRH Safer Technologies Program Introduced
- URL: https://www.fdaweb.com/cdrh-safer-technologies-program-introduced/
- Published: 2019-09-18T12:00:00.000Z
- Updated: 2026-09-15T01:50:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145030

FDA has issued a draft guidance, *Safer Technologies Program for Medical Devices*, introducing a new, voluntary program for certain medical devices and device-led combination products that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. The [document](https://www.fda.gov/media/130815/download?ref=fdaweb.com) says devices and device-led combination products are eligible for the program if they are subject to review under a PMA, de novo request, or 510(k).

“FDA believes that this Safer Technologies Program (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…,” it says.

Included in the guidance are Introduction, Background, Program Principles, Factors for STeP Acceptance and Review Process, Mechanism for Feedback on Development of Devices in STeP, and an Appendix.