FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program (STeP) intended to encourage device tech that significantly improves safety as compared to current devices on the market.

In a new FDA release, Commissioner Dr. Scott Gottlieb said that since its inception in late 2016, 110 devices have received a Breakthrough Device designation and eight have received clearance.

The head of the federal watchdog said that the agency has finalized its guidance on the Breakthrough Devices Program. The finalized guidance “outlines program policies, features and the process for manufacturers to follow when choosing to pursue the breakthrough designation,” Gottlieb said in its FDA release.

The guidance includes “several program options to efficiently address device development topics,” the FDA said in its release. These options include meetings between the FDA and sponsors and efforts to improve the efficiency of the agency’s review resources for easier entry of devices onto the market without compromised standards, according to the release.

Gottlieb also outlined steps the agency is taking to establish its STeP pathway, which it imagines will be similar to the breakthrough device program. Instead of a focus on devices and technologies that diagnose or treat life-threatening illnesses or debilitating diseases or conditions, the STeP pathway would focus on devices that innovate to improve the safety of devices and look to reduce complications or the rate of adverse events, the FDA said.

“For example, consider an orthopedic device that treats a condition that is not considered to be life-threatening or irreversibly debilitating. This device would not meet the Breakthrough Devices Program criteria because it is not intended to treat a life-threatening or irreversibly debilitating disease or condition; however, we will consider whether a device like this could qualify for the planned STeP program if it had an innovative safety mechanism that was intended to reduce post-surgical complications,” Gottlieb said in the FDA release.

The FDA said that it will release an additional detail on the program next year on how it will “apply principles and features of the current Breakthrough Devices Program” to devices that significantly improve safety as compared to existing options.

“Today’s actions are an important step in our ongoing efforts to ensure an efficient, transparent and scientifically robust system for ensuring patients have access to safe, high quality medical devices. We continue to encourage device manufacturers to consider the Breakthrough Devices Program for innovative, lifesaving devices, and, in the near future, our goal is to have STeP as an option for those devices with new advances and adaptations that could lead to a reduction in risk to patients or their providers,” Gottlieb said in the federal watchdog’s release. “In the coming months, you’ll hear more from us about our thoughts on STeP and how it could be used to bring important advances to device safety and innovation to improve public health.”

Last month, the FDA released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria.

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