Earlier this year, the Food and Drug Administration announced its Medical Device Safety Action Plan, along with recent updates to modernize and enhance the FDA’s 510(k) and De Novo review processes. Now they have announced plans to take 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 FDA 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. These include devices such as the first blood test to aid in the evaluation of concussion in adults and an artificial-intelligence based device to detect certain diabetes-related eye problems.
FDA said it plans to put forth additional detail next year on STeP related to how it would apply principles and features of the current Breakthrough Devices Program to devices with the potential for significant safety improvements as compared to available treatment or diagnostic options. For instance, it will consider how to 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.
As FDA works to set up the STeP program, they have also finalized guidance on the Breakthrough Devices Program. This final guidance outlines program policies, features and the process for manufacturers to follow when choosing to pursue the breakthrough designation.
The final guidance outlines several program options to efficiently address device development topics as they arise to best facilitate efficient development, such as sprint discussions—meetings between the FDA and sponsors who need timely resolution of focused issues, such as testing protocols—requests for feedback on a data development plan, and requests for clinical protocol agreement. 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.
In the coming months, FDA will release more on STeP and how it could be used to bring important advances to device safety and innovation to improve public health.
