FDA plans to improve medical device cybersecurity


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.