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CDRH Issues 2024 Safety and Innovation Reports

Reports highlight CDRH actions to advance medical device safety and innovation and build on these efforts this year.

FOR IMMEDIATE RELEASE
April 17, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH)

Today, CDRH is issuing two companion reports that detail the Center's commitment to further advance our core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to our 2018 Medical Device Safety Action Plan and features steps we have taken in recent years to assure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights our work to advance innovation and the progress we have made to make the U.S. market more attractive to top device developers.

As we have long stated, safety and innovation are not polar opposites, but rather two sides of the same coin. Our focus on safety and innovation stems from our vision to protect and promote the public health by assuring that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices.

Since 2009, CDRH has focused our efforts on advancing the development of safer, more effective medical devices that provide a significant benefit to the public health. As such, we enhanced our clinical trial and premarket review programs, including the 510(k) and De Novo pathways, and created new programs like the Breakthrough Devices Program, the Safety and Performance Based Pathway and the Safer Technologies Program to help reduce barriers for innovators. As a result of these actions and other past and ongoing efforts, the number of innovative medical devices authorized annually in the U.S. has increased five-fold since 2009.

In parallel, we took significant actions to improve device safety and enhanced our ability to identify and address new safety signals. We achieved an ambitious set of goals outlined in our 2018 Medical Device Safety Action Plan to help ensure patient safety throughout the Total Product Life Cycle (TPLC) of a medical device. We made improvements and updates to our medical device reporting programs, including updating the Manufacturer and User Facility Device Experience (MAUDE) database, vastly improved our recalls program, and took steps to ensure the timely communication and resolution of new or known safety issues.

And throughout, we partnered with patients and incorporated their voices into our work, including establishing our Patient Science and Engagement Program, because at the end of the day, improving the health and the quality of life of people is at the core of our public health mission.

We are proud of the progress we've made to advance innovation and improve the safety of medical devices, and we continue to build on these efforts, as resources and additional capabilities permit. One of the challenges we face, though, is the sheer volume of products and producers. Today there about 257,000 different types of medical devices on the U.S. market, made by approximately 22,000 manufacturing facilities worldwide, and CDRH authorizes roughly a dozen new or modified devices every business day. Despite that, the number of new or increased known safety issues involve only a small fraction of technologies and many can be addressed without any changes to the device itself. However, the impact to people can be significant, which is why we need to continuously take steps to advance both safety and innovation.

This year, we will take additional actions to help further ensure innovative, high-quality, safe, and effective devices are developed and marketed to U.S. patients. As further detailed in the 2024 Innovation Report, three actions we plan to take this year include: reimagining our premarket review program, expanding our footprint in geographical innovation centers, and launching a new home as a health care hub to extend first-class care into the home. Additionally, as detailed in the 2024 Safety Report, three actions we plan to take this year include: expanding a program to assist companies improve their device quality efforts, strengthening active surveillance, and enhancing the medical device recall process.

Through these new actions and the work detailed in the 2024 Safety and Innovation reports, CDRH remains committed to furthering our mission to protect and promote the public health and ensure our organization is well-positioned to meet the needs of all people and changes in the medical device ecosystem.

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