FDA’s release of the “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” is the vision for the future as related to medical device safety. The plan outlines how the agency will encourage innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed.
The key actions related to medical device safety include:
- 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
- Integrate the Center for Devices and Radiological health’s premarket and postmarket offices to advance The Total Product Life Cycle approach to device safety
Go to https://www.fda.gov/MedicalDevices/default.htm to download the Medical Device Safety Action Plan.