FDA envisions STeP as a complement to the Breakthrough Devices Program. Products that offer significant safety advantages compared to existing technology, but otherwise do not meet the criteria for breakthrough status because the device is not intended for use for life-threatening diseases or otherwise irreversibly debilitating conditions. For eligibility into the STeP program, the device should be “reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more of the following:

1. a reduction in the occurrence of a known serious adverse event,
2. a reduction in the occurrence of a known device failure mode,
3. a reduction in the occurrence of a known use-related hazard or use error, or an improvement in the safety of another device or intervention

Devices designated into the STeP program could be eligible for benefits similar to those available for breakthrough devices, including increased interaction with the agency. Draft guidance outlining STeP was issued in September 2019, and we analyzed the initial program parameters online here.

While the final guidance nearly mirrors its draft form, the final version differs in that it adds the following clarifications.

• Benefit-risk profile. The final guidance explains how FDA will evaluate the significance of a safety benefit within the context of the overall benefit-risk framework for the particular device and proposed intended use. The final guidance adds, “The device should be reasonably expected to make a clinically meaningful improvement in the prevalence and/or severity of the safety issue typically associated with a particular treatment or diagnostic.”

• Reducing known serious adverse events. In the finalized version, FDA adds examples of medical devices that the agency would determine can “be reasonably expected to result in a significant reduction in the occurrence of a known serious adverse event, based on the principles of operation of the device.” For example, FDA cites a “new implantable device that is reasonably expected to significantly reduce or eliminate debilitating symptoms that are known to manifest after implantation of devices of the same type” as meeting the agency’s standards under this sub-part.

• Improvement in safety. As part of STeP, FDA intends to consider if the medical device is reasonably expected to offer a “specific and significant type of improved safety benefit for another medical device or intervention.” Although this improved safety benefit might come from the medical device being evaluated for inclusion in STeP acting as an accessory to other medical devices, it may also apply to finished devices that are not accessories. In the final guidance, FDA adds explication as to when FDA would determine there is improved safety for finished devices that are not accessories; for example, FDA says, “[t]reatment of some pediatric illnesses may require multiple surgical interventions throughout the life of a patient, and a device that allows for a single intervention instead could be considered to significantly reduce the risks associated with that treatment by obviating the need for multiple interventions.”

• STeP timeframe. The process for acceptance into STeP requires a submission through the QSub pathway. FDA plans to use a 60 day review period to evaluate STeP applications. The final guidance specifically notes that “the timeframe for review of the marketing submission may take longer for devices in STeP than for other less novel devices.”

• Adverse event reporting. FDA specifically notes in the final guidance: “Inclusion of a modified device into this program will not impact the obligations or responsibilities of a manufacturer with respect to any recall or correction.” FDA further expounds on how “inclusion in the program should not be interpreted as a decision on the relative or absolute safety or effectiveness of that medical device, or any other medical products.”

Of note, while the breakthrough program has seen a recent increase in popularity due to the Medicare Coverage of Innovative Technology (MCIT) coverage pathway for breakthrough medical devices, this coverage decision does not appear to extend to the STeP program at this point in time. Accordingly, the benefits of the STeP program are currently limited to more frequent and timely interaction with FDA. Accordingly, the benefits of entry into the program are likely to be derived earlier in the FDA process. However, like the breakthrough designation program, we expect that FDA will similarly require some level of data to support the criteria for entry into the program.

FDA said it may need up to 60 days to operationalize STeP following issuance of the final guidance, and the agency does not intend to accept requests for inclusion in the program within this time period. FDA anticipates accepting program entrance requests beginning on March 8, 2021.

If you may be interested in applying to STeP, or have any questions about medical device application submissions more generally, feel free to contact your Hogan Lovells attorney or any of the authors of this alert.

Authored by Randy Prebula and Lina Kontos