Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices. Last year, the FDA approved first artificial pancreas and the first blood test to evaluate traumatic brain injury. The FDA plays a crucial role in the efficient development of these technologies.
Dr. Jeffrey Shuren, have been advancing new policies to drive innovation in medical product development by taking novel approaches to regulation. Under Dr. Shuren’s leadership, the FDA has undertaken several important initiatives to prioritize and enhance our approach to medical device safety.
This new Action Plan outlines our vision for how the FDA can continue to enhance our programs and processes to assure the safety of medical devices. This plan focuses on five key areas: Establish a robust medical device patient safety net in the U.S.; Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations; Spur innovation towards safer medical devices; Advance medical device cybersecurity; and Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.
To start, CDRH is implementing a more integrated approach to device safety throughout the TPLC by pursuing a reorganization that integrates CDRH’s premarket and postmarket offices across functions, and allows our experts to leverage their knowledge of pre- and postmarket information to optimize decision-making. As we move to the TPLC structure, we are exploring various new regulatory options to streamline timely implementation of postmarket mitigations as part of the Action Plan. As part of the Action Plan, we also are exploring what further actions we can take to spur innovation towards technologies that can make devices and their use safer.
Another important element of the Action Plan recognizes that safety and innovation should go hand in hand.
These new steps will be all the more effective because of the extensive work we’ve done over the past years to modernize our data gathering infrastructure around device safety – such as our Unique Device Identification System (UDI) and use of real world evidence (RWE).
Medical device safety is a key priority for the FDA. We’re committed to protecting American patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.
