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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety

For Immediate Release:
Statement From:

Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. We’ve taken several steps to enhance how we deliver on this mission through the goals we laid out in our Medical Device Safety Action Plan that the FDA announced earlier this year and through recent updates on our initiatives to modernize and enhance the FDA’s 510(k) and De Novo review processes. Today we’re taking 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 we first 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.

As part of gaining the Breakthrough designation, the sponsors developing these novel devices receive early and more frequent engagement with the FDA. This more collaborative process helps to make the development and review process more efficient and to facilitate generation of robust evidence required to support product marketing authorizations, while maintaining the quality of our review and ensuring that our review standards are met.

As we indicated in the Medical Device Safety Action Plan, innovation and safety are complementary. Spurring innovation to develop safer, more effective devices and devices that address unmet needs can also mean patients have safer options for the treatment of their conditions. The best technological advances should lead to more lives saved, fewer adverse events, and improved quality of life. 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. 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.

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 orthopedic 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.

While we envision that these two programs, Breakthrough and STeP, would be two different pathways—one for new devices to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions that address an unmet medical need and one for devices that treat less serious conditions and innovate on safety—we believe they could have similar impact in spurring the development of and giving patients more timely access to important medical devices. If the same programmatic benefits that encourage device manufacturers to create devices to treat or diagnose a life-threatening disease could be applied to bring innovation to medical device safety for less serious conditions, the potential public safety impact could be tremendous.

As we work to set up the STeP program, today we’ve also finalized our guidance on the Breakthrough Devices Program. We know how important it is to bring transparency and clarity to the device premarket process. This is especially true with devices that bring access to life-saving treatments or diagnostic tools to patients and their families. This final guidance outlines program policies, features and the process for manufacturers to follow when choosing to pursue the breakthrough designation.

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. This is because breakthrough device innovations that are highly novel can be challenging and more complex for the FDA to assess. 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.

To achieve these goals, 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.

Today’s actions are an important step in our ongoing efforts to ensure an efficient, transparent and scientifically robust system for ensuring patients have access to safe, high quality medical devices. We continue to encourage device manufacturers to consider the Breakthrough Devices Program for innovative, lifesaving devices, and, in the near future, our goal is to have STeP as an option for those devices with new advances and adaptations that could lead to a reduction in risk to patients or their providers.

In the coming months, you’ll hear more from us about our thoughts on STeP and how it could be used to bring important advances to device safety and innovation to improve public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Alison Hunt

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