The Food and Drug Administration has announced it is finalising guidance on its existing Breakthrough Devices Program as well as announcing plans for a Safer Technologies Program (STeP).
The Breakthrough Devices Program aims to accelerate the development of device and give patients access to products that more effectively diagnose or treat life-threatening or life-changing conditions.
The guidance on the Breakthrough Devices Program aims to provide what the FDA calls a more “agile” process, which involves more consultation between themselves and the device manufacturer.
In a statement on its website, FDA commissioner Scott Gottlieb, and Jeff Shuren, director of the Center for Devices and Radiological Health said: “We plan to put forth additional detail next year on STeP related to how we 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, we 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.
“For example, consider an orthopaedic 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. Or, consider a medical imaging device that does not meet the Breakthrough criteria but significantly reduces radiation exposure in comparison to similar devices, which would be both beneficial to patients and clinicians. Such devices would have safety advantages compared to current devices and therefore would be the kinds of devices that may qualify for inclusion in STeP."
The FDA went on to say that the programs will be on two different pathways in that one will treat life-threatening and life-changing conditions, and the other treats less serious conditions and “innovates” on safety – but could both have a similar impact both in terms of safety and access.
