FDA Issues Final Guidance on the Safer Technologies Program (STeP) for Medical Devices

Manatt on Health

On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal of expediting development and FDA review of medical devices or device-led combination products that are likely to offer safer treatment or diagnosis of certain diseases and conditions as compared to currently available alternatives. Such alternatives may include currently marketed medical devices or other standard care practices, such as use of FDA-approved drugs and biologics.

STeP was designed as a complement to the existing Breakthrough Devices Program, another voluntary pathway that aims to accelerate access to treatments and diagnostics offering additional benefits over existing options. However, in comparison to the Breakthrough Devices Program, which requires eligible devices to treat or diagnose life-threatening or irreversibly debilitating diseases and conditions, STeP is intended for devices that address less-serious diseases and conditions.

STeP intends to expedite device development and review by facilitating earlier and more regular interaction with FDA, increasing the resources dedicated to review, allowing for flexible clinical study design, and accelerating review of marketing authorization submissions and, as necessary, review of manufacturing and quality systems compliance.

In order to be eligible for STeP, devices must meet several criteria. First, devices must be subject to review under a 510(k) premarket notification, De Novo request or premarket approval (PMA). Additionally, in the case of device-led combination products, the device-related component must be responsible for any added safety benefit, rather than the drug/biologic-related component.

In addition to satisfying the above general criteria, devices must also meet the following specific eligibility criteria. To be considered for STeP, devices or device-led combination products must not be eligible for the Breakthrough Devices Program. In other words, the devices must treat or diagnose diseases and conditions that are non-life-threatening and/or result in only reasonably reversible consequences. Additionally, the product must be likely to significantly improve the risk-benefit profile of an existing treatment or diagnostic by offering innovative safety improvements. These improvements can include (1) a reduction in the occurrence of a known serious adverse event, failure mode, or use-related hazard or use error or (2) an improvement in the safety of another device or intervention. It is important to note that, while STeP is not intended for products that directly treat or diagnose life-threatening diseases and conditions, the agency does intend to consider life-threatening adverse events and failure modes associated with device use when evaluating improved safety. Additionally, for products that satisfy the criterion of offering improved safety of another device or intervention, the agency permits that these products act as accessories to existing devices. Though increased safety is the focus of STeP, FDA indicates that any improvement in safety should not negatively impact device effectiveness or introduce any significant alternative safety-related concerns.

Interested sponsors can submit a request for inclusion into STeP via pre-submission. Such a request can be made before, in parallel with or after a submission for marketing authorization, though acceptance into the program early in the development phase is expected to offer the greatest benefit. Once a request for STeP inclusion is received, sponsors can expect to hear from the agency within 30 days and receive a final decision within 60 days.

Sponsors that are granted inclusion into STeP are subsequently able to receive timely feedback from FDA via two STeP-specific avenues (in addition to the traditional pre-submission pathways). First, sponsors can request a sprint discussion, which resembles an accelerated pre-submission process, in which the sponsor and FDA discuss and reach an agreement on a particular item (i.e., a study protocol) within a pre-defined timeline. Secondly, sponsors can request a review of a Data Development Plan, which streamlines development and review by outlining all anticipated clinical and non-clinical data requirements as well as the timelines for collecting and submitting that data.

FDA expects to begin considering STeP inclusion requests starting March 8, 2021. The finalized STeP guidance document can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices.

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