Experts: FDA Cyber Guide Provides Key Testing, Documentation Updates

Medical device experts voiced their approval of FDA's recent draft guidance that lays out how device manufacturers should address cybersecurity in their premarket submissions. While they welcomed FDA’s thorough list of documents and testing, which they say will give manufacturers a goal to shoot for to make their products more resilient to cybersecurity threats, they also told Inside Health Policy there is still some uncertainty surrounding the draft guidance. Namely, one expert said it is unclear whether industry will...