--- title: "PCCP, Predetermined Change Control Plan | MedTech Terms" description: "FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. Plain-English Software & AI definition for MedTech teams, with examples and rela" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-ml-pccp#term", "name": "Predetermined Change Control Plan", "alternateName": "PCCP", "description": "A Predetermined Change Control Plan (PCCP) is a document, included in a marketing submission, that describes planned modifications to an AI/ML-enabled device, the methods used to develop, validate, and implement those modifications, and the impact on the device.", "url": "https://medtechterms.com/terms/ai-ml-pccp", "termCode": "ai-ml-pccp", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/ai-ml-pccp#article", "headline": "PCCP, Predetermined Change Control Plan", "description": "FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.", "url": "https://medtechterms.com/terms/ai-ml-pccp", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/ai-ml-pccp" }, "about": { "@id": "https://medtechterms.com/terms/ai-ml-pccp#term" }, "articleSection": "Software & AI", "inLanguage": "en", "keywords": "Predetermined Change Control Plan, PCCP, 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": "FDA PCCP Guidance", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA - AI/ML-Enabled Medical Devices", "url": "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "IMDRF - Software as a Medical Device", "url": "https://www.imdrf.org/working-groups/software-medical-device-samd", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/samd#term", "name": "Software as a Medical Device", "alternateName": "SaMD", "url": "https://medtechterms.com/terms/samd" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/good-machine-learning-practice#term", "name": "Good Machine Learning Practice", "alternateName": "GMLP", "url": "https://medtechterms.com/terms/good-machine-learning-practice" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Software & AI", "item": "https://medtechterms.com/terms?cat=Software%20%26%20AI" }, { "@type": "ListItem", "position": 4, "name": "Predetermined Change Control Plan", "item": "https://medtechterms.com/terms/ai-ml-pccp" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Predetermined Change Control Plan [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle)[Global Markets](/ecosystems/global-markets)PCCP # Predetermined Change Control Plan FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A Predetermined [Change Control](/terms/change-control) Plan (PCCP) is a document, included in a marketing submission, that describes planned modifications to an AI/ML-enabled device, the methods used to develop, validate, and implement those modifications, and the impact on the device. ## What this means in practice PCCPs let manufacturers update AI/ML models within an authorized envelope without a new submission, while preserving safety and effectiveness controls. ## Use cases 1 scenario 1 ### Continuous learning chest-X-ray triage SaMD ML & RA team The sponsor includes a Predetermined [Change Control](/terms/change-control) Plan in the 510(k): allowed modifications (retraining cadence, new sites), the protocol (data governance, performance thresholds), and impact assessment. Outcome After clearance, the team retrains quarterly under the PCCP without filing a new submission for each update. ## Cross-references ### Used by Things that build on this term. - [ AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [ Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive) ### See also Closely related context worth reading. - [ Change Control ](/terms/change-control) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. ](/terms/good-machine-learning-practice)[ 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 Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. Adjacent lesson ](/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)[ Software & AI Software Safety Classification IEC 62304 classes A, B, C reflecting potential harm from software failure. ](/terms/software-safety-class?from=samd-and-ai) ### Software Team Onboarding · From this learning path [ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304?from=software-team-onboarding)[ Cybersecurity Threat Modeling A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat. Adjacent lesson ](/terms/threat-modeling?from=software-team-onboarding)[ 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?from=software-team-onboarding)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf?from=software-team-onboarding) ### AI/ML Devices Deep Dive · From this learning path [ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. Adjacent lesson ](/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)[ Software & AI Generative AI in Medical Devices Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow. ](/terms/generative-ai-devices?from=ai-ml-devices-deep-dive) Cited by Where this term appears across MedTech Terms. Learning paths (3) - [SaMD & AI/ML Devices](/paths/samd-and-ai)Lesson 7 of 9 - [Software Team Onboarding](/paths/software-team-onboarding)Lesson 12 of 12 - [AI/ML Devices Deep Dive](/paths/ai-ml-devices-deep-dive)Lesson 2 of 9 Ecosystems (3) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Global Markets](/ecosystems/global-markets) ## Mentioned in recent activity 1 entry FDA 510(k) (1) [Tyto Insights for Wheeze Detection (with PCCP) ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252844) Tyto Care , Ltd. · 2026-06-02 ## Latest in MedTech [View all](/latest?term=ai-ml-pccp) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - 510(k) 2026-06-02 [Tyto Insights for Wheeze Detection (with PCCP) ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252844) Tyto Care , Ltd. ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 IMDRF· 1 1. [1 FDA PCCP Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence) 2. [2 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) 3. [3 IMDRF - Software as a Medical Device Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) 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 PCCP Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=ai-ml-pccp) Learn in 60 seconds Card Lesson Quiz FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. - · PCCPs let manufacturers update AI/ML models within an authorized envelope without a new submission, while preserving safety and effectiveness controls. Remember this FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. Related terms - [Software as a Medical Device(SaMD) ](/terms/samd) - [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) You may also need Auto-suggested from Software & AI and shared keywords. - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Predetermined Maintenance vs PCCP ](/terms/predetermined-maintenance) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Pre-Submission Meeting(Q-Sub) ](/terms/pre-submission) - [Data Governance (AI/ML) ](/terms/data-governance) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) [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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)