In 2021, the FDA established the “Safer Technologies Program” (STeP) to cover medical devices that do not qualify for the Breakthrough Devices Program. While these devices may have their own innovations, the diseases they target are not as severe and do not meet the urgency criteria for “breakthrough devices”.
What is the Safer Technologies Program (STeP)?
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.
What are the benefits of STeP?
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.
When to submit a STeP entrance request?
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).
How to submit a STeP entrance 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.
What to include in a STeP entrance request
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.
When will I find out if my device will be included in STeP?
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.
What to expect from the FDA if device is included in SteP
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.
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