--- title: "ICSMA, ICS Medical Advisory | MedTech Terms" description: "CISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ics-medical-advisory#term", "name": "ICS Medical Advisory", "alternateName": [ "ICSMA", "CISA Medical Device Advisory", "ICS-MEDICAL-ADVISORY" ], "description": "ICS Medical Advisories (ICSMAs) are official cybersecurity advisories published by CISA for medical devices, distinct from the more general ICS-Advisory (ICSA) series for industrial control systems. Each ICSMA describes affected products, vulnerability details (CVE IDs, CVSS scores), risk evaluation, mitigations, and the responsible manufacturer's coordinated disclosure timeline. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. ICS Medical Advisory [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)ICSMA # 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. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition ICS Medical Advisories (ICSMAs) are official cybersecurity advisories published by CISA for medical devices, distinct from the more general ICS-Advisory (ICSA) series for industrial control systems. Each ICSMA describes affected products, vulnerability details ( [CVE](/terms/cve) IDs, [CVSS](/terms/cvss) scores), risk evaluation, mitigations, and the responsible manufacturer's coordinated disclosure timeline. ICSMAs are the public artifact of FDA-coordinated and [H-ISAC](/terms/h-isac)\-coordinated vulnerability disclosures and are referenced by hospital procurement, HDOs, and insurers when evaluating device cyber risk. What the regulation says CISA publishes ICSMAs under its sector-specific advisory authority and coordinates closely with FDA's CDRH. FDA's 2023 Cybersecurity in Medical Devices guidance expects manufacturers to have processes for [coordinated vulnerability disclosure](/terms/cvd) with CISA. Section [524B](/terms/section-524b)'s post-market expectations align with the ICSMA workflow. ## What this means in practice Receiving an ICSMA is a defining moment for a medical device manufacturer's post-market cybersecurity program. The advisory triggers customer notifications, board-level reporting, often FDA Form 3500A scrutiny if patient harm is plausible, and a measurable test of the manufacturer's [CVD](/terms/cvd) and post-market plan. Manufacturers should map their disclosure SOPs explicitly to the ICSMA process and know who at CISA, FDA, and [H-ISAC](/terms/h-isac) their coordination contacts are before an incident. Common pitfalls - • 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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity CISA Known Exploited Vulnerabilities Catalog(KEV) CISA's authoritative list of CVEs with confirmed in-the-wild exploitation, with mandatory federal remediation deadlines. ](/terms/kev)[ Cybersecurity Common Vulnerabilities and Exposures(CVE) A globally unique identifier for a publicly disclosed cybersecurity vulnerability. ](/terms/cve)[ Cybersecurity Common Vulnerability Scoring System(CVSS) An industry-standard 0–10 score that quantifies the severity of a software vulnerability. ](/terms/cvss)[ Cybersecurity Coordinated Vulnerability Disclosure(CVD) A documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers. ](/terms/cvd) ### More in Cybersecurity · Same category [ Cybersecurity Health Information Sharing and Analysis Center(H-ISAC) Member-driven nonprofit that operates the trusted sharing community for cyber and physical threat intelligence across the healthcare sector. ](/terms/h-isac)[ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b)[ Cybersecurity Vulnerability Exploitability eXchange(VEX) A machine-readable statement that explains whether a known vulnerability is actually exploitable in a specific product. ](/terms/vex) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 CISA· 1 MDCG· 1 HSCC· 1 1. [1 CISA Coordinated Vulnerability Disclosure Process Verified CISA · cisa.gov ](https://www.cisa.gov/coordinated-vulnerability-disclosure-process) 2. [2 MDCG Cybersecurity Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 3. [3 HSCC - Health Sector Coordinating Council Verified HSCC · healthsectorcouncil.org ](https://healthsectorcouncil.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Acronym ICSMA Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=ics-medical-advisory) Learn in 60 seconds Card Lesson Quiz CISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN. - · Receiving an ICSMA is a defining moment for a medical device manufacturer's post-market cybersecurity program. - · The advisory triggers customer notifications, board-level reporting, often FDA Form 3500A scrutiny if patient harm is plausible, and a measurable test of the manufacturer's CVD and post-market plan. - · Manufacturers should map their disclosure SOPs explicitly to the ICSMA process and know who at CISA, FDA, and H-ISAC their coordination contacts are before an incident. Remember this Watch out: Discovering ICSMA process for the first time during an incident, pre-establish CISA and FDA contacts and run a tabletop. Related terms - [CISA Known Exploited Vulnerabilities Catalog(KEV) ](/terms/kev) - [Common Vulnerabilities and Exposures(CVE) ](/terms/cve) - [Common Vulnerability Scoring System(CVSS) ](/terms/cvss) - [Coordinated Vulnerability Disclosure(CVD) ](/terms/cvd) - [Health Information Sharing and Analysis Center(H-ISAC) ](/terms/h-isac) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Vulnerability Exploitability eXchange(VEX) ](/terms/vex) You may also need Auto-suggested from Cybersecurity and shared keywords. - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG) ](/terms/hph-cpg) - [IMDRF Principles and Practices for Medical Device Cybersecurity ](/terms/imdrf-cyber-principles) - [Legacy Device Cybersecurity ](/terms/legacy-device-cyber) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) - [Medhacking ](/terms/medhacking) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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