Postmarket· Jun 18, 2026
H-ISAC and Medical Device Threat
The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS.
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Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 3 of 3 articles in Postmarket
The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS.
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The CISA KEV catalog explained: who must act on it, how it drives SBOM and VEX triage, and how it fits postmarket obligations under the FDA's guidance.
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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.
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