The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health outlines a vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices throughout the TPLC, to provide for the timely communication and resolution of new or increased known safety issues, and to advance innovative technologies that are safer, more effective and address unmet needs.
Specifically, this plan focuses on how FDA can:
1. Establish a robust medical device patient safety net in the United States
2. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
3. Spur innovation towards safer medical devices
4. Advance medical device cybersecurity
5. Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and postmarket offices and activities to advance the use of a TPLC approach to device safety