Omnibus bill sets up cyber requirements for medical devices under FDA review, including SBOM

A provision in the House-Senate omnibus appropriations package will require the Food and Drug Administration to establish cybersecurity requirements for medical device applications including the submission of a Software Bill of Materials and plans to address “post-market vulnerabilities.”

The medical device bill is part of the 4,155-page omnibus package unveiled Tuesday that will provide full fiscal 2023 funding for agencies and departments, along with $44.9 billion in assistance and support for Ukraine.

The FDA is currently working on its...