Developers of devices that include software need to be aware of the US Food and Drug Administration’s “cyber device” expectations, two former FDA reviewers said during a late February webinar.
Key Takeaways
- Almost every device that includes software will fall under the US FDA's cyber device regulations, cybersecurity professional Naomi Schwartz said during a recent webinar.
- Central requirements for cyber devices include submitting a complete software bill of materials (SBOM), identifying vulnerabilities, and developing a plan to address them