U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.

By: Nancy Morrison, RQM+ Executive Director, Regulatory and Quality Consulting Services and Kevin Go, RQM+ Project Engineer

Kicking off the year on a high note, the U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document earlier this month. The final guidance document comes just a little over a year after the draft was first released, which is especially impressive timing given the Center for Devices and Radiological Health's (CDRH) workload with all the COVID-related submissions. Per the Guidance Document, the STeP is a:

new, 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; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions.”

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FDA’s SteP is based off the Breakthrough Devices Program and share many similarities between their processes, timelines, mechanism of feedback, and level of interaction with FDA. Like the Breakthrough Devices Program, PMA, De Novo, and 510(k) products are all eligible for STeP. The major difference between the programs is in the eligibility criteria.

The criteria for a medical device or combination device to participate in the STeP is:

  • Device is for less serious diseases or conditions and, consequently, is not eligible for the Breakthrough Devices Program

  • Device meets one of the following:

    • Reduction in known serious adverse events

    • Reductions in known device failure mode

    • Reduction in known use related hazard or use error

    • Improvement in safety of another device or intervention

There are a few important points to note regarding eligibility for the STeP designation. First, the eligibility for the second criteria should not be based on hypothetical adverse events/failure modes. To be able to demonstrate a significant safety improvement, the device must show a reduction in an “known” safety event. It is also important to note that inclusion in STeP does not change the statutory and regulatory requirements of your devices. While being able to demonstrate reduction in a “known” safety risk would improve the benefit-risk determination, it would not change the devices overall risk classification (i.e. a PMA would still be a PMA). The SE evaluation for 510(k)s will also not be impacted by inclusion of the device in STeP, meaning that “substantial safety innovations” may still raise different questions of safety and effectiveness and be kicked off the flowchart.

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To submit a request for your medical device or device-led combination product for the SteP designation you must do so in a Q-Submission, with the request being the only item in the Q-Submission. FDA expects to request any additional information within 30 days of the request and a final decision made within 60 days. An example of the type of information which should be included can be found in Appendix 1 of the Guidance Document.

To expedite timely reviews, device manufacturers can expect faster feedback from FDA via “Sprints”, meaning single topic pre-submission meetings and 45-day timeline per topic. Additional benefits of the program include:

  • Flexibility in clinical study design

  • Expedited pre-approval inspection for PMA submissions

  • Opportunity for more interaction with FDA via regular status updates outside formal submissions

Just like the FDA Breakthrough Devices Program, there is a commitment on the part of the sponsor to respond quickly to interactive review questions to take full advantage of this expedited program. This increased communication is especially beneficial for those complex submissions where clinical data is needed or where multiple interactions with the Agency are common.

FDA also notes that multiple regulatory submissions for devices intending to address the same safety issue may be pending simultaneously. Interestingly though, the guidance does not provide examples for what happens if one device addressing the same safety issue gets cleared before another. They provide similar examples in the Breakthrough Guidance, so it is possible that something similar will happen where the benefit-risk for the devices still under review will have to be adjusted after the first one is cleared, or they may end up being disqualified.

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The RQM+ team is very excited about this new program! STeP fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need them. While the Guidance Document has been finalized, however, it is important to note that FDA is not accepting any requests at this time. FDA anticipates that the “Agency may need up to 60 days to perform activities to operationalize this Safer Technologies Program following issuance of this guidance”, meaning they still need additional time to be able to train the CDRH review and policy staff on how to interpret and implement the new program appropriately. FDA is hosting a webinar on February 1, 2021, where we will hopefully learn more information about their progress and when the program will go live.

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Sources:
[1] U .S. Food & Drug Administration (FDA). Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff. Published 6 January 2021. Accessed 6 January 2021. https://www.fda.gov/media/130815/download
[2]
U.S. Food & Drug Administration (FDA). Safer Technologies Program (SteP) for Medical Devices. Published 6 January 2021. Accessed 6 January 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices
[3] U.S. Food & Drug Administration (FDA). Breakthrough Devices Program. Published December 2018. Accessed 6 January 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program

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