“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….”
“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.” Read the full press release here.
Source: 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 – By January 28, 2019. FDA.
