--- title: "The FDA's AI/ML SaMD playbook. · AI SaMD Playbook" description: "The FDA has moved further than any other regulator on AI-enabled SaMD · publishing a public list of authorized devices, finalising the Predetermined Change…" lang: en json-ld: | [ { "@context": "https://schema.org", "@graph": [ { "@type": "WebSite", "@id": "https://ai-samd.com/#website", "url": "https://ai-samd.com/", "name": "AI SaMD Playbook", "description": "Working reference for regulating AI/ML Software as a Medical Device: FDA, EU AI Act, MHRA, Health Canada and NMPA guidance, model risks, and cybersecurity for RA/QA teams.", "inLanguage": "en" }, { "@type": "Organization", "name": "Blue Goat Cyber", "url": "https://bluegoatcyber.com" } ] }, [ { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://ai-samd.lovable.app/" }, { "@type": "ListItem", "position": 2, "name": "Crosswalk", "item": "https://ai-samd.lovable.app/crosswalk" }, { "@type": "ListItem", "position": 3, "name": "The FDA's AI/ML SaMD playbook.", "item": "https://ai-samd.lovable.app/regulators/fda" } ] }, { "@context": "https://schema.org", "@type": "Article", "headline": "The FDA's AI/ML SaMD playbook.", "description": "The FDA has moved further than any other regulator on AI-enabled SaMD · publishing a public list of authorized devices, finalising the Predetermined Change Control Plan (PCCP) guidance, and setting expectations around Good Machine Learning Practice that the rest of the world is now adopting.", "about": "United States · Food and Drug Administration", "mainEntityOfPage": "https://ai-samd.lovable.app/regulators/fda", "publisher": { "@type": "Organization", "name": "Blue Goat Cyber", "url": "https://bluegoatcyber.com" } } ] ] --- [AI SaMD Playbook ](/) Sections[Crosswalk](/#crosswalk)Tools Search Ctrl K[Talk to us →](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) [← Back to crosswalk](/#crosswalk) FDA United States · Food and Drug Administration # The FDA's AI/ML SaMD playbook. The FDA has moved further than any other regulator on AI-enabled SaMD · publishing a public list of authorized devices, finalising the Predetermined Change Control Plan (PCCP) guidance, and setting expectations around Good Machine Learning Practice that the rest of the world is now adopting. Posture · Leading · statutory pathway, lifecycle-aware Last reviewed · April 2026 Key facts Authorized AI/ML devices 1,000+ PCCP final guidance Aug 2025 (reissued) Primary submission 510(k) · De Novo · PMA Cybersecurity guidance Feb 2026 (final) §01 ## Predetermined Change Control Plans The PCCP lets a manufacturer pre-authorize a defined set of model modifications without a new marketing submission. It is not a blank check: the plan must specify exactly what may change, how the change will be implemented, and how its impact will be assessed. - Description of Modifications · what specifically can change (weights, thresholds, input modalities). - Modification Protocol · the methods, data, performance criteria, and verification used. - Impact Assessment · how the change affects safety, effectiveness, and the benefit-risk profile. - Anything outside the PCCP is an unauthorized change · and a recall risk. §02 ## Good Machine Learning Practice (GMLP) Co-authored with Health Canada and the MHRA, the ten GMLP principles are now the default lens through which reviewers read AI/ML submissions. They are not regulation, but deficiency letters routinely cite them. - Multi-disciplinary expertise across the product lifecycle. - Good software engineering and security practices baked in. - Clinical study participants and data sets representative of the intended population. - Human-in-the-loop performance and monitoring of deployed models. §03 ## Cybersecurity for AI-enabled devices The FDA's February 2026 cybersecurity guidance · which supersedes the 2023 and June 2025 versions · folds Quality Management System considerations directly into the premarket submission. For AI SaMD that means the QMS must demonstrably govern the model lifecycle: threat models include the model itself (poisoning, evasion, extraction, prompt injection), and the SBOM reflects the ML stack and third-party model dependencies. - QMS evidence · secure development, design controls, and supplier management explicitly tied to the ML pipeline. - SBOM coverage of ML frameworks, model artifacts, and tokenizer/weights provenance. - Vulnerability management plan with explicit handling of model-layer CVEs. - Secure update mechanism aligned with the PCCP's modification protocol. §04 ## Transparency and labelling The October 2024 draft guidance on AI-enabled device software functions raises the bar on what manufacturers must communicate to users · intended use, model inputs and outputs, performance by subgroup, known limitations, and the clinician's role in interpreting results. Key takeaways 1. 01 Author a PCCP early · it shapes your data pipeline, not just your filing. 2. 02 Treat the GMLP principles as a checklist reviewers will silently grade you against. 3. 03 Bring the model inside your threat model, SBOM, and vulnerability program. 4. 04 Plan a model card and labelling strategy before the first user sees an output. References - [FDA AI/ML-Enabled Device List ↗](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) - [PCCP Final Guidance (reissued Aug 18, 2025) ↗](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence) - [Good Machine Learning Practice (GMLP) ↗](https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles) - [Cybersecurity in Medical Devices · QMS & Premarket Submissions (Feb 3, 2026) ↗](https://www.fda.gov/media/119933/download) [ ← Previous Health Canada ](/regulators/health-canada)[ Next → EU AI Act × MDR ](/regulators/eu-ai-act) © 2026 AI SaMD Playbook · Sponsored by Blue Goat Cyber [Crosswalk](/crosswalk)[Colophon](/colophon) Editorial reference only. Not legal or regulatory advice.