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The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS advisories, NVD, MITRE ATT&CK for ICS, and vendor PSIRTs.
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What the CISA Known Exploited Vulnerabilities (KEV) catalog is, how medical device manufacturers should use it in SBOM/VEX triage, and how the FDA treats KEV-listed CVEs.
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What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents reviewers look for.
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