FDA’s STeP Program

FDA’s STeP Program

The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.1 This particular pathway is reserved for devices with unique and other-wise unavailable treatments to serious conditions, but what about devices associated with conditions less serious than those eligible for the Breakthrough Devices Program? The answer to this question is the FDA’s Safer Technologies Program or STeP.

STeP is targeted at medical devices that treat or diagnose conditions that are milder than what is eligible for the Breakthrough Devices Program, and even includes conditions that are non-life-threatening or reasonably reversible.2 There are two eligibility factors for STeP:

  1. Your device can’t be eligible for the Breakthrough Devices Program
  2. Your device should provide substantial safety innovations by reducing the occurrence of a known serious adverse event/device failure mode, or demonstrate an improvement in the safety of another device.

The goal of STeP is to provide quick access to medical devices that satisfy the above by expediting their journey through the regulatory processes, while also preserving the statutory standards of pathways such as 510(k) or De Novo. On top of reducing the overall time spent in the regulatory pathway before getting to market, STeP also provides manufacturers an opportunity to interact directly with the FDA, receiving feedback from the agency in a much more time-effective manner. As part of the goal to optimize time, manufacturers can hear back on the agency’s decision for inclusion or denial in STeP within 60 days of the entrance request and will get requests for additional information within 30 days, if necessary.

In early January, the FDA released the final guidance document on STeP, providing the industry with counsel on how to enter STeP and what to expect as a participant. If you are unsure how to navigate the regulatory landscape for your medical device, EMMA International can help! We have a team of experts who are on top of all the new programs introduced by the agency and can help prepare a tailor-made regulatory strategy for your device. Contact us at info@emmainternational.com or call 248-987-4497 to find out more today!


1FDA (Jan 2021) Breakthrough Devices Program retrieved on 01/05/2021 from: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

2FDA (Jan 2021) Safer Technologies Program (STeP) for Medical Devices retrieved on 01/05/2021 from: https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices

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