Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. FDA is taking steps on two additional device programs: finalizing guidance on our existing Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
STeP is an idea we first outlined in the April 2018 Medical Device Safety Action Plan, which aims to encourage innovation and market entry of device technologies that are safer than current alternatives.
The current Breakthrough Devices Program is intended to advance the development of innovative devices and help give patients more timely access to products that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions. These devices offer new ways to treat or diagnose a disease or condition, have significant advantages over existing treatment or diagnostic alternatives or provide another public health benefit. Since the program was authorized in late 2016, 110 devices have received a Breakthrough Device designation and eight have received marketing authorization.
As part of gaining the Breakthrough designation, the sponsors developing these novel devices receive early and more frequent engagement with the FDA. This more collaborative process helps to make the development and review process more efficient and to facilitate generation of robust evidence required to support product marketing authorizations, while maintaining the quality of our review and ensuring that our review standards are met.
The best technological advances should lead to more lives saved, fewer adverse events, and improved quality of life. This is the core of our vision with STeP: to support important safety advancements in medical devices to help improve patients’ quality of life and advance our public health mission. For instance, FDA will consider how we could apply Breakthrough principles and features to products intended to treat or diagnose non-life-threatening diseases or conditions, but which offer substantial safety innovations that either reduce the occurrence of a serious adverse event or other safety issue; address a known device failure mode or common user error; or provide for significant safety advantages for users.
These two programs, Breakthrough and STeP, would be two different pathways—one for new devices to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions that address an unmet medical need and one for devices that treat less serious conditions and innovate on safety. This final guidance outlines program policies, features and the process for manufacturers to follow when choosing to pursue the breakthrough designation.
The idea with this program is to provide a more agile process for developers of breakthrough devices to obtain feedback from the FDA on their innovations. This is because breakthrough device innovations that are highly novel can be challenging and more complex for the FDA to assess. To achieve these goals, the final guidance outlines several program options to efficiently address device development topics as they arise to best facilitate efficient development. These options improve the efficiency of the FDA’s review resources and are designed to facilitate entry of state-of-the-art medical technologies to the market without compromising the standards for marketing authorization.
This 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.
