ICS Medical Advisory
CISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN.
Definition
ICS Medical Advisories are CISA public vulnerability advisories for healthcare products. They commonly identify affected versions, vulnerabilities, CVEs, severity information, mitigations and reporting acknowledgments. FDA or Health-ISAC involvement and a manufacturer disclosure timeline are not guaranteed elements of every advisory.What this means in practice
Use ICSMAs as inputs to vulnerability assessment, remediation and communication. Separately assess applicable medical device reporting, corrections/removals and customer-notification obligations. An ICSMA alone does not mandate board reporting or Form FDA 3500A submission.Examples
- Illustrative: A hospital cybersecurity team reviewed a recent ICSMA regarding a widely used imaging system to understand the vulnerability's impact and implement recommended mitigations before the manufacturer released a patch.
- Illustrative: During a procurement review, an HDO's risk management committee identified an ICSMA associated with a vendor's infusion pump, prompting further questions about the manufacturer's remediation plan and long-term security commitments.
- Illustrative: A MedTech manufacturer received an ICSMA designation for a discovered flaw in their connected diagnostic device, triggering an immediate internal investigation, customer notification process, and accelerated patch development.
- •Discovering ICSMA process for the first time during an incident, pre-establish CISA and FDA contacts and run a tabletop.
- •Treating ICSMAs as marketing damage to be minimized, incomplete or evasive advisories destroy trust with hospital customers far more than the underlying vulnerability.
- •Ignoring competitor ICSMAs, they are the best public signal of what credible attacks against your product class look like.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsCISA catalog of vulnerabilities exploited in the wild, with risk-prioritization requirements for covered federal systems.
A globally unique identifier for a publicly disclosed cybersecurity vulnerability.
An industry-standard 0–10 score that quantifies the severity of a software vulnerability.
A documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.
More in Cybersecurity
· Same categoryMember-driven nonprofit that operates the trusted sharing community for cyber and physical threat intelligence across the healthcare sector.
The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A machine-readable statement that explains whether a known vulnerability is actually exploitable in a specific product.
Where this term appears across MedTech Terms.
Sources
5 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Official-source claim check:
CISA publishes ICSMAs describing healthcare-product vulnerabilities and mitigations; publication does not itself trigger FDA reporting.
Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.
Remaining verification limits
- Secondary regulatory, standards-clause, market-prevalence or procurement claims were not fully substantiated by accessible original text.
- 1CISA Coordinated Vulnerability Disclosure ProcessTier 2 VerifiedCISAcisa.gov
- 2MDCG Cybersecurity GuidanceTier 2 VerifiedMDCGhealth.ec.europa.eu
- 3HSCC - Health Sector Coordinating CouncilTier 4 VerifiedHSCChealthsectorcouncil.org
- 4CISA Orthanc ICSMATier 2 UncheckedCISAcisa.gov
- 5FDA final guidance, February 3, 2026Tier 2 UncheckedFDAfda.gov
Inline markers like [1] jump to the matching reference above.