--- title: "PCCPs and cybersecurity: what changes when your AI model…" description: "FDA's Predetermined Change Control Plans let AI/ML devices ship updates without a new submission - but the cyber risk surface moves with every retrain. Here's…" lang: en json-ld: | [ { "@context": "https://schema.org", "@graph": [ { "@type": "WebSite", "@id": "https://medtechcybertips.com/#website", "url": "https://medtechcybertips.com/", "name": "MedTech Cyber Tips", "description": "The ultimate organized guide to medical device cybersecurity.", "inLanguage": "en-US", "publisher": { "@id": "https://medtechcybertips.com/#org" }, "potentialAction": { "@type": "SearchAction", "target": "https://medtechcybertips.com/topics?q={search_term_string}", "query-input": "required name=search_term_string" } }, { "@type": "Organization", "@id": "https://medtechcybertips.com/#org", "name": "MedTech Cyber Tips", "url": "https://medtechcybertips.com/", "logo": "https://medtechcybertips.com/icon-512.png", "sponsor": { "@type": "Organization", "name": "Blue Goat Cyber", "url": "https://bluegoatcyber.com", "sameAs": [ "https://home.bluegoatcyber.com/", "https://codebluechart.com/", "https://why.bluegoatcyber.com/", "https://spdf.bluegoatcyber.com/", "https://threatmodel.bluegoatcyber.com/", "https://pentesting.bluegoatcyber.com/", "https://premarket.bluegoatcyber.com/", "https://fdaresponse.bluegoatcyber.com/", "https://postmarket.bluegoatcyber.com/", "https://goatwatch.bluegoatcyber.com/" ] } } ] }, { "@context": "https://schema.org", "@type": "BlogPosting", "headline": "PCCPs and cybersecurity: what changes when your AI model updates itself", "description": "FDA's Predetermined Change Control Plans let AI/ML devices ship updates without a new submission - but the cyber risk surface moves with every retrain. Here's how to scope a PCCP that doesn't quietly invalidate your 524B package.", "datePublished": "2026-06-10", "dateModified": "2026-06-10", "url": "https://medtechcybertips.com/updates/pccp-cyber-intersection-2026", "mainEntityOfPage": "https://medtechcybertips.com/updates/pccp-cyber-intersection-2026", "author": { "@type": "Person", "@id": "https://medtechcybertips.com/authors/editorial-team", "name": "MedTech Cyber Tips Editorial Team" }, "reviewedBy": { "@type": "Person", "@id": "https://medtechcybertips.com/authors/editorial-team", "name": "MedTech Cyber Tips Editorial Team" }, "publisher": { "@type": "Organization", "name": "MedTech Cyber Tips", "url": "https://medtechcybertips.com", "sponsor": { "@type": "Organization", "name": "Blue Goat Cyber" } }, "articleSection": "FDA" }, { "@context": "https://schema.org", "@type": "Person", "@id": "https://medtechcybertips.com/authors/editorial-team", "url": "https://medtechcybertips.com/authors/editorial-team", "name": "MedTech Cyber Tips Editorial Team", "jobTitle": "Medical Device Cybersecurity Editors", "description": "The MedTech Cyber Tips editorial team is a group of practitioners with hands-on experience across FDA premarket cybersecurity submissions, Secure Product Development Framework (SPDF) implementation, medical device threat modeling, and postmarket vulnerability management. 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Here's how to scope a PCCP that doesn't quietly invalidate your 524B package. Reviewed by [MedTech Cyber Tips Editorial Team](/authors/editorial-team) · Published Jun 10, 2026 · Last reviewed July 2026 Predetermined Change Control Plans (PCCPs) are now the default vehicle for shipping AI/ML model updates post-clearance. The cybersecurity catch: every model update is also a software update, and every software update can shift your [SBOM](/glossary/sbom), your threat model, and your attack surface. Three things to put in your [PCCP](/glossary/pccp) narrative if your device is a 'cyber device' under §[524B](/glossary/524b): 1\. A scoped statement of which cybersecurity controls are inside the PCCP envelope (typically: none - model retraining alone should not change auth, crypto, or transport). 2\. A trigger that pulls a change back into a new submission if a retrain requires new data sources, new APIs, or new ML-serving infrastructure. 3\. SBOM regeneration as a release gate, so each PCCP-eligible update still produces a fresh SBOM and [VEX](/glossary/vex) for ongoing postmarket monitoring. The pattern reviewers reward: a PCCP that explicitly excludes cyber-relevant components from autonomous change, with a clean handoff back to the 524B process when the line is crossed. Source [FDA PCCP final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-machine-learning-enabled-medical-devices) More updates - [ MDCG 2019-16 Rev.2 at six months: Notified Body audit patterns Six months in, Notified Body audits under MDCG 2019-16 Rev.2 show three clear failure modes - narrative-only SBOMs, CVD policies without operational evidence, and traceability gaps between security risk controls and design outputs. Oct 2026](/updates/mdcg-2019-16-rev2-six-month-retrospective) - [ Three years of Section 524B: the deficiencies that never went away Three-year retrospective on Section 524B enforcement: SBOM depth, VEX justification, and CVD operational evidence remain the top three categories of cyber deficiencies. Two new patterns emerged in 2026 - AI/ML threat-model gaps and weak end-of-support labeling. Oct 2026](/updates/524b-three-year-checkin) - [ IEC 81001-5-1 Amendment 1 reaches FDIS - what MedTech teams should track Amendment 1 to IEC 81001-5-1 (health software security lifecycle) is in Final Draft International Standard ballot. It sharpens SBOM, CVD, and postmarket vulnerability expectations - and it's the standard EU Notified Bodies are quietly aligning MDCG 2019-16 audits against. Sep 2026](/updates/iec-81001-5-1-amendment-1-fdis) MedTech Cyber Tips The organized, end-to-end guide to medical device cybersecurity, from concept through postmarket. Part of the Blue Goat Cyber family. 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