The US Food and Drug Administration (FDA) plans to tackle security issues related to medical devices and has released a plan of action it means to implement in the near future.
Broadly, plan is as follows:
- Establish a robust medical device patient safety net in the US
- 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.