March 18, 2024
Daily News
FDA may seek authority to require medical devices be designed with cybersecurity
The Food and Drug Administration's medical device center may ask Congress for authority to require manufacturers to build cybersecurity into their product designs and, once a product is marketed, to disclose any vulnerabilities as they are identified.
The agency also envisions requiring device makers to include in their pre-market submissions a Software Bill of Materials that would be made available to customers and users so they can better manage networked assets and be aware of which devices may be vulnerable....