2 More Steps for Medical Device Innovation
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say the agency has taken two additional steps to spur innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives. They say the Safer Technologies Program (STeP) aims to encourage innovation and market entry of device technologies that are safer than current alternatives.
In a media announcement, Gottlieb and Shuren say that STeP is to “support important safety advancements in medical devices to help improve patients’ quality of life and advance our public health mission. 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.”
Additional details on STeP are to be released this year to tell how FDA will 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.
The second effort described in the announcement is the finalization of a guidance on the Breakthrough Devices Program. Gottlieb and Shuren say the program’s goal is to provide a more agile process for developers of breakthrough devices to obtain feedback from FDA on their innovations. “This is because breakthrough device innovations that are highly novel can be challenging and more complex for FDA to assess,” they write. “We know from experience that more frequent interactions with device developers during product development can result in identifying more efficient ways of evaluating these novel devices’ benefits and risks and facilitate a timelier premarket review, which is especially important since timely patient access is critical with these types of devices.”
The guidance outlines several program options to efficiently address device development topics as they arise to best facilitate efficient development, such as “spring discussions” (meetings between FDA and sponsors who need timely resolution of focused issues such as testing protocols), requests for feedback on a data development, and requests for clinical protocol agreement. “These options improve the efficiency of 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,” the two say.