In April, the U.S. FDA released its Medical Device Safety Action Plan, which outlined actions to improve medical device safety and efficacy. Now, FDA officials are making headway on two additional device programs: the Breakthrough Device Program, as well as the new Safer Technologies Program, or STeP.
“As we work to set up the STeP program, we’ve finalized our guidance on the Breakthrough Devices Program,” FDA Commissioner Scott Gottlieb, MD, and Center for Devices and Radiological Health Director Jeff Shuren, MD, say in a statement. “We know how important it is to bring transparency and clarity to the device premarket process”—especially with devices that bring life-saving diagnostic tools to the industry, they say.
“This final guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the breakthrough designation,” Gottlieb and Shuren add.
Moreover, the STeP program, which was first outlined in the Medical Device Safety Action Plan, aims to encourage innovation and market entry of device technologies that are safer than current alternatives, Gottlieb and Shuren say. After all, they add, “The best technological advances should lead to more lives saved, fewer adverse events, and improved quality of life.” That, Gottlieb and Shuren say, is the core vision of STeP: to endorse innovations in medical device safety in a bid to improve public health.
“We envision that STeP would be available for devices that do not otherwise meet the criteria to be considered a breakthrough device in our current program, but through innovative designs, have the potential to be significantly safer than currently available alternative treatments or diagnostics,” they say in a statement.
In the coming months, the FDA will “put forth additional detail 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,” Gottlieb and Shuren. In other words, stay tuned.