The Breakthrough Devices Program for Non-Breakthrough Devices

On September 19, FDA issued a draft guidance that continues its trend to incentivize innovation and increase collaboration with industries in order to expedite the premarket review process, the “Safer Technologies Program for Medical Devices,” or STeP. STeP is aimed at speeding up access to market for innovative devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics, but that are not eligible for the FDA's 2017 Breakthrough Devices Program (BDP) because they do not address diseases or conditions that are life-threatening or irreversibly debilitating. STeP-eligible devices are those intended for less serious diseases or conditions such as non-life-threatening diseases or reasonably reversible conditions.

STeP Eligibility

"Reasonably expected to significantly improve safety" means that, without introducing new serious hazards, the product will potentially result in any of the following:

  • Reducing the occurrence of a known serious adverse event
  • Reducing the occurrence of a known device failure mode
  • Reducing the occurrence of a known use-related hazard or use error
  • Improving the safety of another device or intervention, for instance, as an accessory

In addition to the above criterion, eligibility for STeP also will depend on whether improvement of the product’s risk-benefit profile is accomplished through substantial safety innovations, such as innovative technological features or innovative uses of technology. STeP would be available not only for products that replace other devices, but also for products that have the potential to significantly improve safety over the current standard of care, e.g., drugs, biologics or other technologies. Like BDP, STeP is a voluntary program available for medical device products that are subject to premarket approval (PMA), premarket notification (510(k)) or a De Novo classification request. To achieve the maximum benefit, requests for acceptance into the STeP program should be made prior to premarket submission.

For products accepted into the STeP program, FDA intends to provide similar benefits as those in BDP, as resources permit, for early engagement with the agency and expedited and interactive review. Among the tools FDA will offer participants are review of the sponsor's Data Development Plan—a high level plan outlining data collection expectations for the entire product lifecycle—and "sprint discussions" for timely resolution of a non-clinical and clinical evaluation issue in a set time frame. Participants in STeP also will benefit from involvement of FDA senior management, interactive communications, priority review, consideration of real-world evidence use in clinical study designs and, where appropriate, use of post-market data collection in the evaluation of clinical impact, with review teams trained to apply novel approaches to challenging issues. What acceptance into STeP is not intended to do, however, is provide a determination as to the type of premarket submission needed for the device, a device’s classification or whether the device is an accessory, and if so, its risk classification.

FDA's Trend to Support and Foster Innovation

STeP is a welcome expansion of the statutorily mandated BDP and demonstrates FDA’s continued trend toward flexible thinking, innovation and risk/benefit calculations that go beyond what absolutely is required under the 21st Century Cures Act. However, there are some small differences at least in the descriptions of the benefits of participation in STeP versus BDP, if not in the exercise. For instance, senior management’s active role in reviewing and assessing submissions and hand-picking appropriate expert team leads under BDP, as required by 21st Century Cures Act, is not mentioned in the STeP guidance. On the other hand, BDP only references statutorily mandated PMA devices in connection with the appropriate use of post-market data, while STeP references De Novo devices also, and expressly references use of real-world data in clinical study designs. Although this difference may be due to the continued evolution in FDA thinking regarding the balance between pre- and post-market evidence and availability of real-world data, it also could be due to a recognition by FDA of the increase in submissions for software as a medical device (SaMD) and alignment with the SaMD pre-certification program principles regarding that balance.

According to a report to Congress by former FDA Commissioner Scott Gottlieb, as of the end of fiscal year 2018— which was just under one year from the date of publication of the BDP draft guidance—FDA granted BDP status to 71 out of 100 applications and received 13 marketing submissions for breakthrough devices. Hopefully industry can expect similar success with STeP, though the fact that BDP activities are “significantly more time- and labor-intensive for FDA staff” may limit the success of STeP unless further resources are allocated for these and other programs. As noted by Dr. Jeff Shuren, CDRH Director, at last week's AdvaMed conference, it’s the same people now being asked to do more with the same resources.