On this page:
- What is the Safer Technologies Program (STeP)?
- What are the benefits of STeP?
- Is my device eligible?
- When to submit a SteP entrance request
- How to submit a SteP entrance request
- What to include in a SteP entrance request
- When will I find out if my device will be included in STeP?
- What to expect from the FDA if included in STeP
- Resources related to the Safer Technologies Program
- Contact Us
The Safer Technologies Program (STeP) is a 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. Devices that are eligible for STeP, unlike those that are eligible for the Breakthrough Devices Program, may include devices that are intended to treat or diagnose diseases or conditions that are non-life-threatening or reasonably reversible.
The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
The Safer Technologies Program is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. It offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA in a timely way. Manufacturers can also expect interactive and timely communications, early engagement on Data Development Plans, sprint discussions, and senior management engagement to support the program, as resources permit. Learn more about the STeP principles and features in Sections III and V of the Safer Technologies for Medical devices final guidance.
Devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo classification are eligible for inclusion in STeP if both of the following eligibility factors are met:
|Reference Section of Guidance
|First Eligibility Factor
|Not eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device
|Second Eligibility Factor
|Should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for at least one of the following
|a. a reduction in the occurrence of a known serious adverse event
|b. a reduction in the occurrence of a known device failure mode
|c. a reduction in the occurrence of a known use-related hazard or use error
|d. an improvement in the safety of another device or intervention
To receive the most benefit from program participation, ideally a request seeking inclusion for a device in STeP will be sent prior to sending your marketing submission (for example, premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request).
Sponsors interested in participating in STeP as part of their device development should submit a Q-Submission requesting inclusion in STeP with this request highlighted in the cover letter. This request should be the only request in the Q-Submission. The procedures for submitting a Q-Submission are outlined in the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
The FDA may identify devices that could be good candidates for the Safer Technologies Program and recommend that sponsors of such devices consider applying to the program.
The FDA recommends that your request include information to describe the device, the proposed indications for use, expected safety improvement, regulatory history, how your device meets the STeP objectives, and what type of marketing submission you plan to submit to the FDA for your device. Learn more about what to include in your request in Appendix 1 of the Safer Technologies for Medical Devices final guidance.
The FDA intends to request any other information related to the STeP entrance request within 30 days of receiving your request. You can expect to receive a letter communicating the device's inclusion or denial for inclusion in STeP within 60 calendar days of the FDA receiving your request.
It is helpful when a sponsor is available and responsive to any FDA requests for additional information throughout the review timeline. If the FDA does not receive the information requested promptly, it may result in denial of the program entrance request.
If your device is included in STeP, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options including sprint discussions and requests for discussion on a Data Development Plan. Learn more about these options in Section V of the Safer Technologies for Medical Devices guidance.
FDA will also allocate additional resources to future regulatory submissions, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions, as resources permit.
- Safer Technologies for Medical Devices Final Guidance
- Breakthrough Devices Program Final Guidance
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Medical Device Safety
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (Benefit Risk Final Guidance)
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics - Guidance for Industry and Food and Drug Administration Staff
For any questions about the Safer Technologies Program please contact [email protected].