The Safer Technologies Program (STeP) is a new voluntary program modeled after the FDA’s Breakthrough Devices Program. It reduces the time to develop and obtain marketing authorization of devices that offer a significant safety advantage in treating and/or diagnosing less serious diseases or conditions than those targeted by the Breakthrough Devices Program. This article describes the eligibility criteria and features of the program.
STeP was motivated by the FDA’s Medical Device Safety Action Plan, specifically to help drive the marketplace to develop safer technologies by providing regulatory incentives and scientific expertise. Like the Breakthrough Devices Program, STeP aims to expedite the development, assessment and review of eligible devices. There are several program options available to interact with the FDA’s experts and receive timely feedback on issues as they arise during premarket review. The FDA issued the final guidance on STeP on January 6, 2021 and anticipated a 60-day timeframe to operationalize the program.
The program is intended for devices or device-led combination products that are reasonably expected to significantly improve the safety of currently available medical treatments or diagnostics through innovative features. While the Breakthrough Devices Program targets devices that treat life threatening or irreversibly debilitating diseases or conditions, STeP focuses on devices for treating or diagnosing non-life-threatening or reasonably reversible conditions.
Eligible devices are those that are subject to review under a 510(k) premarket notification, De Novo classification request or premarket approval (PMA) and are not eligible for the Breakthrough Devices Program based on the less serious nature of the disease/condition targeted. This should not be interpreted to mean that a device that is denied breakthrough device designation is appropriate for inclusion in STeP. In addition, by means of substantial safety innovations, the devices should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic by providing one or more of the following:
- A reduction in the occurrence of a known device failure mode that is likely to result in serious adverse health consequences
- A reduction in the occurrence of a known use-related hazard/use error (e.g., an innovation that reduces use error associated with an operational feature)
- A reduction in the occurrence of a known serious adverse event (e.g., modification to the fundamental principles of operation of a device that significantly reduces serious infections)
- An improvement in the safety of another device or intervention (e.g., an innovation that replaces an invasive diagnostic procedure with a non-invasive method)
The programmatic features that the FDA intends to utilize to expedite the development of the device and review of subsequent regulatory submissions (e.g., pre-submissions, Investigational Device Exemption (IDE) applications, and marketing submissions) include:
- Interactive and timely communication
- Increased review team support (e.g., including senior management to support efficient dispute resolution)
- Additional resources to review regulatory submissions (it is anticipated that devices eligible for STeP will present technological or design innovations that may raise novel and/or complex scientific or regulatory issues that will require more in-depth review)
- Timely post-market data collection for PMAs and De Novo requests
- Consideration of proposals for efficient and flexible clinical study design
- Expedited review of manufacturing and quality system compliance for devices with preapproval inspection requirements
To enable early and regular communication with the FDA as device development progresses, the agency intends to offer several voluntary mechanisms for feedback. Sponsors may use one or more of these options when submitted through the Q-submission process (referencing “STeP Interaction Submission”):
- Sprint discussions to facilitate timely resolution of clinical or non-clinical evaluation issues (within 45 days)
- Review of a data development plan (an optional, high-level document outlining data collection expectations, including non-clinical testing approaches and/or clinical evaluation strategies, for the entire device lifecycle)
- Traditional pre-submissions where the scope is consistent with typical requests for feedback applicable to the Q-submission Program
The FDA expects a commitment from the sponsor to work collaboratively to resolve all scientific and regulatory issues as efficiently as possible. Regular status update meetings may be set up (outside of a formal regulatory submission) to discuss general progress, next steps, and/or plans for future discussions.
Requests for inclusion in STeP must be submitted via the Q-submission process. Manufacturers are encouraged to submit a STeP entrance request prior to sending the marketing application to receive the most benefit from the program. The agency may consider requests for inclusion in parallel or after a marketing submission has been made. The appendix in the guidance document outlines the recommended content for the request. The timeframe for an inclusion/denial decision is 60 calendar days (with intent to request additional information, if required, within 30 days). If additional information is requested by the agency, the entrance request is not placed on hold, therefore sponsors must be available and responsive to FDA requests. A program mailbox has been set up to submit any inquiries regarding the program.
STeP is predicated on the FDA’s belief that there is an important public health benefit in advancing medical devices that offer a significant safety advantage in treating and diagnosing less serious diseases or conditions. Patients may experience fewer serious adverse events and the overall clinical benefit of a medical device may be improved.
This program highlights the agency’s commitment to improving safety and spurring innovation, and is a welcome counterpart to the Breakthrough Devices Program. Medical device companies should be encouraged to consider inclusion in the program early in device development to take full advantage of a fast-track approval.