--- title: "Predetermined Maintenance vs PCCP… | MedTech Terms" description: "Distinction between routine maintenance changes (cybersecurity patches, minor fixes) and PCCP-controlled algorithm changes." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/predetermined-maintenance#term", "name": "Predetermined Maintenance vs PCCP", "description": "Not every software change to an AI/ML device requires a PCCP - cybersecurity patches, bug fixes, and infrastructure updates often fall under standard software maintenance. 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A PCCP, conversely, specifically addresses pre-specified, planned modifications to an AI/ML device's algorithm, often related to its learning or adaptation capabilities." } }, { "@type": "Question", "name": "When is a PCCP typically required?", "acceptedAnswer": { "@type": "Answer", "text": "A PCCP is typically required when an AI/ML device is designed to adapt or be modified post-market in ways that directly impact its algorithm's behavior or performance. This plan outlines the scope, methods, and validation processes for these specific algorithmic changes." } }, { "@type": "Question", "name": "Can cybersecurity updates be considered predetermined maintenance?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, cybersecurity updates are generally considered predetermined maintenance. They maintain the security and functionality of the software without altering the fundamental algorithm that defines the device's medical function, as long as they are managed within a robust software development lifecycle." } }, { "@type": "Question", "name": "How do regulatory bodies view the distinction between these two concepts?", "acceptedAnswer": { "@type": "Answer", "text": "Regulatory bodies like the FDA emphasize that this distinction is crucial for efficient oversight. Clearly defining what falls under routine maintenance versus a PCCP helps manufacturers manage post-market changes effectively and prevents unnecessary premarket submission burdens." } } ] } ] } --- [ 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 Maintenance vs PCCP [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle) # Predetermined Maintenance vs PCCP Distinction between routine maintenance changes (cybersecurity patches, minor fixes) and PCCP-controlled algorithm changes. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Not every software change to an AI/ML device requires a [PCCP](/terms/ai-ml-pccp) - cybersecurity patches, bug fixes, and infrastructure updates often fall under standard software maintenance. PCCPs specifically govern pre-specified algorithm modifications. What the regulation says The FDA guidance "Content of Premarket Submissions for Device Software Functions" and "Marketing Submission Recommendations for Next Generation Sequencing (NGS) - Based SSoP" distinguish between changes necessitating a [Predetermined Change Control Plan](/terms/ai-ml-pccp) (PCCP) and routine software maintenance. Per the FDA, a PCCP is for planned modifications to an Artificial Intelligence/Machine Learning (AI/ML) device’s algorithm, while maintenance covers issues like cybersecurity updates or bug fixes, which typically do not require new premarket submissions if managed under established software lifecycle processes. ## What this means in practice Drawing the boundary clearly in the submission and SOPs prevents unnecessary submissions and confusion at audit time. ## Examples - A manufacturer releases a software patch to address a newly discovered cybersecurity vulnerability in their AI-powered diagnostic imaging system, classifying it as predetermined maintenance rather than a PCCP change. - A company submits a PCCP outlining how its AI-driven diabetes management app will be updated annually to incorporate new clinical guidelines into its glucose prediction algorithm. - An infrastructure update to a cloud-based AI medical device, such as switching to a new server provider without altering the AI algorithm itself, is managed as predetermined maintenance. Common pitfalls - • Confusing routine software maintenance activities with changes that require a PCCP can lead to unnecessary regulatory submissions and delays. - • Failing to clearly define the scope of a PCCP in relation to general software maintenance can result in regulatory non-compliance during audits. - • Assuming all AI/ML model retraining constitutes a PCCP-relevant change without distinguishing between performance-enhancing updates and core algorithm modifications is a common misstep. - • Not adequately documenting the rationale for classifying a software change as maintenance versus a PCCP-governed modification can create audit findings. - • Applying a PCCP to non-AI/ML software components or changes that do not alter the pre-specified algorithm is an inefficient regulatory strategy. ## Frequently asked questions What is the primary difference between predetermined maintenance and a PCCP? Predetermined maintenance covers routine software updates such as cybersecurity patches, bug fixes, and infrastructure improvements that do not alter the core algorithmic function. A [PCCP](/terms/ai-ml-pccp), conversely, specifically addresses pre-specified, planned modifications to an AI/ML device's algorithm, often related to its learning or adaptation capabilities. When is a PCCP typically required? Can cybersecurity updates be considered predetermined maintenance? How do regulatory bodies view the distinction between these two concepts? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Software Maintenance Plan IEC 62304 §6 documented plan for handling problem reports, changes, and releases over the software lifecycle. ](/terms/software-maintenance-plan) ### More in Software & AI · Same category [ Software & AI AAMI TIR45(TIR45) AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. ](/terms/aami-tir45)[ Software & AI Adversarial Robustness Resilience of an ML model to inputs deliberately crafted to cause misclassification. ](/terms/adversarial-robustness)[ 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)[ Software & AI Algorithm Change Protocol(ACP) The detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented. ](/terms/algorithm-change-protocol) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [AI / ML in Devices](/ecosystems/ai-ml) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 IMDRF· 1 MDCG· 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 IMDRF - Software as a Medical Device Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) 3. [3 MDCG Software 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) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=predetermined-maintenance) Learn in 60 seconds Card Lesson Quiz Distinction between routine maintenance changes (cybersecurity patches, minor fixes) and PCCP-controlled algorithm changes. - · Drawing the boundary clearly in the submission and SOPs prevents unnecessary submissions and confusion at audit time. - · PCCPs specifically govern pre-specified algorithm modifications. Remember this Watch out: Confusing routine software maintenance activities with changes that require a PCCP can lead to unnecessary regulatory submissions and delays. Related terms - [Software Maintenance Plan ](/terms/software-maintenance-plan) You may also need Auto-suggested from Software & AI and shared keywords. - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive) - [Field Action vs Recall ](/terms/field-action-vs-recall) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Model Drift Monitoring ](/terms/drift-monitoring) [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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