Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation

The FDA’s focus on both safety and innovation stems from our historic mission to protect and promote public health—to assure that medical devices on the U.S. market are high-quality, safe and effective and to facilitate innovation and assure that patients and providers have timely and continued access to these high-quality, safe and effective devices. Spurring innovation to develop safer, more effective devices is key to improving patient safety. We are equally committed to advancing safe and effective products that can address unmet medical needs to reduce the health effects from disease. Both objectives are essential to meeting our public health mission, resulting in more lives saved and improved quality of life.

In the final weeks of 2018, we issued several statements and reports to inform the public about additional actions the FDA was taking to continue to modernize our approach to device safety, building on our April 2018 Medical Device Safety Action Plan and taking into consideration public feedback on this plan. The Action Plan described some of the steps we’ve taken over the past few years to enhance device safety and outlined our vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices. As we noted in the Action Plan and in our statements, innovation and safety go hand-in-hand.

One measure of our success in advancing device innovation is the annual number of novel, safe and effective technologies the FDA approves or clears. Last year marked another record year, supported by the new policies, processes and programs we’ve implemented over recent years to help efficiently promote safe and effective innovation in medical device development. Last year, in 2018, the FDA approved 106 novel devices, surpassing the 40-year record we set in 2017 of 99[1] novel device approvals, and capping off eight years of steady improvement.

The agency has also granted 112 Breakthrough Device Designation requests since the start of the program in April 2015, and, during 2018, approved or cleared nine breakthrough devices.

Just a few examples of innovative new products that have come to market in 2018 as a result of our efficient, risk-based approach to total product life-cycle regulation include: expanded approval of an automated insulin dosing system to include people with diabetes who are as young as age 7; the world’s smallest heart valve for newborns; the first blood test in the world to evaluate mild traumatic brain injury (“concussion”); the first mobile medical app to help treat substance abuse disorders, and technologies using artificial intelligence to detect diabetic retinopathy in adults with diabetes and for aiding providers in the detection of wrist fractures. We also approved the first artificial iris in the U.S. and permitted marketing of a new prescription medical device that measures eye movement as an aid in the diagnosis of concussion. These are among many novel innovations that came to market in 2018.

Our effort to promote innovation is eclipsed only by our commitment to make sure that these products are safe for patients. Our success in providing patients with new treatments and diagnostics, and more options for effective health care, are not coming at the expense of the robust non-clinical and clinical science on which we rely to make our regulatory decisions. For example, due in part to our efforts to strengthen the clinical trial enterprise and leverage real world data, in some cases we’re receiving clinical evidence more quickly and more efficiently and answering postmarket questions we would not have been able to easily address in the past.

In 2019, we’ll continue to move forward with our plans to implement the National Evaluation System for Health Technology (NEST). We also plan to establish premarket pathways that foster innovations to enhance patient safety while continuing to build a more robust patient safety net in the U.S. One way we can promote innovation is to drive competition for developing safer devices. We recently finalized guidance for manufacturers for an alternative 510(k) pathway initially proposed in April—the FDA’s “Safety and Performance Based Pathway”—by which companies would demonstrate they meet safety and performance criteria developed by the FDA based on the performance of more modern predicate devices (cleared, U.S. legally marketed devices) when they seek to bring new devices to patients.

In the coming year, we will begin to establish safety and performance criteria for certain well-understood device types to allow manufacturers to demonstrate they meet the FDA’s criteria, including when it comes to product safety. We will also take forward the other aspects of the 510(k) modernization we recently announced, including consideration of actions that might require new authority, such as making at least some older devices ineligible as predicates.

This year we also expect to issue a proposed framework for the Safer Technologies Program (STeP) and for this we will consider how we could apply Breakthrough Device 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.

Our success in driving better safety and greater innovation depends, in part, on our ability to be innovative. We need to be able to continually adapt our frameworks, try new approaches, and, where necessary, seek new authorities because science does not stand still.

Advances in material science, digital health, 3-D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that can sometimes accompany novel products. We must skate to where the puck will be, and, even better for patients, drive the puck to where it should be. That requires the willingness to embrace and lead change.

By continuing to enhance and implement the right tools and foster an environment that lets the FDA be innovative, while prioritizing patient safety, we’ll continue to deliver on our public health mission.

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.

Footnote:

1. We have defined novel devices as original PMAs, panel track supplement PMAs and de novos. In light of changes made by the 21st Century Cures Act to the Breakthrough Devices Program, we are broadening our definition of novel devices to include HDEs and Breakthrough Device 510(k)s. Under this updated definition we approved/cleared 98 novel devices in CY 2017 and 106 novel devices in CY 2018.