Cybersecurity threats to medical devices are a growing concern that present a potential risk to the safety and effectiveness of medical devices. To address this, the FDA has issued a draftguidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.
The draft guidance details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.
By outlining postmarket recommendations for medical device manufacturers, the FDA encourages manufacturers to address the pressing need to proactively plan for and to assess their products’ cybersecurity vulnerabilities. The FDA encourages public comments on the draft guidance, which will be open for 90 days.