> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# STeP Requests Start 3/8: Report
- URL: https://www.fdaweb.com/step-requests-start-3-8-report/
- Published: 2021-01-13T12:00:00.000Z
- Updated: 2026-09-14T16:42:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148442

Two Hogan Lovells attorneys say FDA will begin accepting Safer Technologies Program (STeP) for Medical Devices requests 3/8\. Writing in an online [analysis](https://www.lexology.com/library/detail.aspx?g=4937ecfd-d738-4974-a2be-fd2bc9d32749&ref=fdaweb.com), the attorneys outline the provisions of a 1/6 final guidance describing the voluntary program for medical device and device-led combination products that offer a significant safety advantage compared to commercially available products.

FDA envisions STeP as a complement to the Breakthrough Devices Program, the attorneys write. For eligibility into the STeP program, a device should be “reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more of: 

- a reduction in the occurrence of a known serious adverse event;
- a reduction in the occurrence of a known device failure mode; and/or
- a reduction in the occurrence of a known use-related hazard or use error, or an improvement in the safety of another device or intervention.

Devices designated into the STeP program could be eligible for benefits similar to those available for breakthrough devices, the attorneys write, including increased interaction with the agency.

The final guidance mirrors the 9/2019 draft, the analysis says, with the addition of these clarifications: 

- benefit/risk profile;
- reducing known serious adverse events;
- improvement in safety;
- STeP timeframe; and
- adverse event reporting.