FDA finalizes guidance on Breakthrough Devices Program

The Food and Drug Administration has finalized guidance for the development of medical devices to effectively diagnose and treat life-threatening or irreversibly debilitating diseases and conditions.

The FDA’s Breakthrough Devices Program—first authorized in late 2016—is intended to 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.

To date, 110 devices have received a Breakthrough Device designation, and eight have received marketing authorization, according to the agency.

“This final guidance outlines program policies, features and the process for manufacturers to follow when choosing to pursue the breakthrough designation,” said FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a written statement. “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.”

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In particular, Gottlieb and Shuren noted that 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.”

In April, the FDA approved the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. The IDx-DR device received expedited review under the agency’s Breakthrough Devices Program.

Also See: FDA clears AI-based system to detect diabetic retinopathy

In addition to issuing final guidance on the FDA’s existing Breakthrough Device Program, Gottlieb and Shuren announced plans for a new Safer Technologies Program (STeP), which would be available for devices that do not otherwise meet the criteria to be considered a breakthrough device, but have the potential to be significantly safer than currently available alternative treatments or diagnostics.

“The best technological advances should lead to more lives saved, fewer adverse events and improved quality of life,” they stated. “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.”

The FDA plans to provide additional details about STeP in 2019, specifically related to how the agency would apply principles and features of the current Breakthrough Devices Program to devices intended to treat or diagnose non-life-threatening diseases or conditions, with the potential for significant safety improvements as compared to available treatment or diagnostic options.

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