--- title: "GMLP, Good Machine Learning Practice | MedTech Terms" description: "Guiding principles for the development of AI/ML-enabled medical devices. Plain-English Software & AI definition for MedTech teams, with examples and related ter" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/good-machine-learning-practice#term", "name": "Good Machine Learning Practice", "alternateName": "GMLP", "description": "Good Machine Learning Practice (GMLP) describes guiding principles - jointly issued by FDA, Health Canada, and the UK MHRA - for developing AI/ML-enabled medical devices that are safe, effective, and high-quality.", "url": "https://medtechterms.com/terms/good-machine-learning-practice", "termCode": "good-machine-learning-practice", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/good-machine-learning-practice#article", "headline": "GMLP, Good Machine Learning Practice", "description": "Guiding principles for the development of AI/ML-enabled medical devices.", "url": "https://medtechterms.com/terms/good-machine-learning-practice", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/good-machine-learning-practice" }, "about": { "@id": "https://medtechterms.com/terms/good-machine-learning-practice#term" }, "articleSection": "Software & AI", "inLanguage": "en", "keywords": "Good Machine Learning Practice, GMLP, Software & AI, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "GMLP Guiding Principles", "url": "https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA - 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Good Machine Learning Practice [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle)GMLP # Good Machine Learning Practice Guiding principles for the development of AI/ML-enabled medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Good Machine Learning Practice (GMLP) describes guiding principles - jointly issued by FDA, Health Canada, and the UK MHRA - for developing AI/ML-enabled medical devices that are [safe](/terms/safe-note), effective, and high-quality. What the regulation says The FDA, Health Canada, and the UK MHRA jointly developed Good Machine Learning Practice (GMLP) principles to guide the development of artificial intelligence/machine learning (AI/ML) enabled medical devices. These principles focus on ensuring the safety, effectiveness, and quality of these devices throughout their lifecycle. GMLP helps inform regulatory expectations, particularly for aspects like data management, model validation, and the performance of human-AI teams. ## What this means in practice GMLP principles inform FDA review expectations, including data management, model validation, and human-AI team performance. ## Examples - A medical device manufacturer implements a comprehensive data governance framework to ensure the quality and unbiased nature of the training data used for its AI-powered diagnostic tool, aligning with GMLP principles for data management. - During the validation of an AI/ML algorithm for detecting anomalies in medical images, a company performs extensive testing across diverse patient populations to demonstrate robust performance and minimize algorithmic bias, as recommended by GMLP. - A change control process is established for an adaptive AI/ML-enabled insulin pump to manage algorithm updates and monitor real-world performance, ensuring consistency with GMLP expectations for continuous learning systems. Common pitfalls - • A common pitfall is failing to establish a robust data management plan that addresses data quality, integrity, and representativeness, potentially leading to biased or inaccurate model performance. - • Misinterpreting GMLP as a static checklist rather than a set of guiding principles can lead to superficial compliance without true assurance of device safety and effectiveness. - • Underestimating the importance of real-world performance monitoring and continuous learning for adaptive AI/ML models can result in undetected performance degradation over time. - • Neglecting to involve multi-disciplinary teams including clinicians, data scientists, and regulatory experts throughout the device development process can lead to overlooked risks and inefficiencies. - • Failing to adequately document the rationale for model choices, data curation, and validation strategies can hinder regulatory review and post-market surveillance. ## Frequently asked questions What is the primary goal of GMLP? The primary goal of GMLP is to ensure that AI/ML-enabled medical devices are developed in a manner that guarantees their safety, effectiveness, and high quality throughout their lifecycle. Which regulatory bodies champion GMLP? Does GMLP apply to all software as a medical device? How does GMLP impact device validation? ## Cross-references ### Governs Things this term applies rules or requirements to. - [ AI/ML-Enabled Medical Device ](/terms/ai-ml-device) ### Contains Sub-elements or required artefacts of this term. - [ Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) ### SaMD & AI/ML Devices · From this learning path [ Software & AI Interoperability Ability of devices and systems to exchange and use information. Adjacent lesson ](/terms/interoperability?from=samd-and-ai)[ Software & AI Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. ](/terms/cds?from=samd-and-ai)[ Software & AI Software in a Medical Device(SiMD) Software embedded in or required to operate a hardware medical device. ](/terms/simd?from=samd-and-ai)[ Software & AI Software of Unknown Provenance(SOUP) Software not developed for medical device use, or lacking adequate development records, incorporated into a device. ](/terms/soup?from=samd-and-ai) ### AI/ML Devices Deep Dive · From this learning path [ Software & AI Model Card Structured documentation of a machine learning model's intended use, performance, and limitations. Adjacent lesson ](/terms/model-card?from=ai-ml-devices-deep-dive)[ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device?from=ai-ml-devices-deep-dive)[ Software & AI Explainability and Interpretability Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction. ](/terms/explainability?from=ai-ml-devices-deep-dive)[ Software & AI Foundation Model (Healthcare) Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting. ](/terms/foundation-model-health?from=ai-ml-devices-deep-dive) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [SaMD & AI/ML Devices](/paths/samd-and-ai)Lesson 8 of 9 - [AI/ML Devices Deep Dive](/paths/ai-ml-devices-deep-dive)Lesson 3 of 9 Ecosystems (2) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 1. [1 GMLP Guiding Principles Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles) 2. [2 FDA - Software as a Medical Device (SaMD) Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd) 3. [3 FDA - AI/ML-Enabled Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [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 Software & AI Acronym GMLP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=good-machine-learning-practice) Learn in 60 seconds Card Lesson Quiz Guiding principles for the development of AI/ML-enabled medical devices. - · GMLP principles inform FDA review expectations, including data management, model validation, and human-AI team performance. Remember this Watch out: A common pitfall is failing to establish a robust data management plan that addresses data quality, integrity, and representativeness, potentially leading to biased or inaccurate model performance. Related terms - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [Software as a Medical Device(SaMD) ](/terms/samd) You may also need Auto-suggested from Software & AI and shared keywords. - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [IMDRF Principles and Practices for Medical Device Cybersecurity ](/terms/imdrf-cyber-principles) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Model Card ](/terms/model-card) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [AAMI TIR45(TIR45) ](/terms/aami-tir45) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.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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