--- title: Your AI-Enabled Device Will Change. Is Your Regulatory Strategy Ready? description: AI is changing medical devices and so are the regulatory challenges. Is your strategy ready? image: https://blog.pqegroup.com/hubfs/AI-Enabled%20Device_Blog.webp --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![Bob Schrader](https://blog.pqegroup.com/hubfs/Bob%20Schrader_ok.jpg) Bob Schrader Director of Medical Device Operations at PQE Group # **Your AI-Enabled Device Will Change. Is Your Regulatory Strategy Ready?** [GxP Compliance](https://blog.pqegroup.com/tag/gxp-compliance) When it comes to medical devices, Artificial Intelligence (AI) has moved from novelty to mainstream. As of October 2026, the [FDA’s list of AI-enabled devices](https://www.fda.gov/medical-devices/artificial-intelligence-enabled-medical-devices/list-artificial-intelligence-enabled-medical-devices) now exceeds 1,600. The vast majority (\>96%) have reached the market through 510(k) clearance; where PMA and De Novo pathways make up the remaining \<4%. Of the 1,600+ devices currently on the list, more than 46% have received authorization between January 2024 and October 2026. The pipeline is full and for many manufacturers, the challenge is no longer securing the first authorization. It is creating a regulatory strategy that can support the device as it evolves over time.  Traditional device regulation assumes a product design that is largely fixed once authorized. AI-enabled software is built to improve; it’s retrained on new data, tuned for new sites, extended to new inputs and more. Each of these improvements introduces new regulatory considerations. While two recent developments (PCCPs and the EU AI Act) are changing how forward-looking organizations plan for that reality, a third challenge (AI within your QMS) is emerging that many manufacturers have yet to fully address.   ## **Planning Your Changes Before You Make Them: PCCPs** FDA initially finalized their guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions in December of 2024. The idea is simple, yet powerful: describe in advance the specific modifications you expect to make and how you will verify them, have the FDA authorize that plan as a part of your marketing submission, and then you may implement those changes according to the authorized plan without a need for a new submission each time. At a high level, a PCCP covers three main topics: a description of planned modification(s), a protocol for how those modifications will be developed, validated, and implemented, and an impact assessment to ensure there’s no significant impact on safety or effectiveness. The upside is real. Faster iterations and reduced costs due to fewer resubmissions. However, the criteria for development of a PCCP is critical to success. The following details are important to consider: - Changes generally need to stay within the device’s intended use – a PCCP cannot be used as a back door for new indications. - Changing the PCCP itself after initial FDA authorization generally means a new submission will be required. - Discussing your plan with the FDA in a pre-submission is encouraged, but be forewarned that the FDA will not authorize a PCCP at the pre-submission stage. ## **Why Some Teams Struggle with PCCPs** A PCCP requires you to commit before you have seen all your data. Draft it too narrowly and it will yield very little value. Draft it too broadly and reviewers will question whether you can truly control what you have promised. A PCCP is not only a regulatory document. It is a promise that your design controls, data management, risk management and post-market processes must remain for the life of the device. The most commonly observed failure I’ve observed is not a weak algorithm, but a quality system that is not robust enough to support and execute the promises made within the PCCP. These types of gaps tend to surface quite late and often become quite expensive for the organization to fix. ## **The Bigger Picture: Lifecycle Thinking, Globally** The PCCP is one piece of broader shift toward a total product lifecycle view. FDA’s January 2025 guidance on [AI-enabled device software functions](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing) (still a draft at our last check) ties together data management, design, documentation and performance monitoring. The message is consistent: device authorization is merely the starting line, not the finish. In Europe, the [EU AI Act](https://artificialintelligenceact.eu/) layers additional requirements on top of MDR and IVDR, rather than replacing them. Following the 2026 Digital Omnibus (Regulation (EU) 2026/1744), the EU AI Act's high-risk AI requirements for AI enabled devices and other regulated products, including many that require Notified Body involvement, will become applicable August 2, 2028. This delay is not a reprieve. In fact, manufacturers selling in both the US and EU markets are better served by a single, documentation and evidence packet strategy, rather than by two parallel compliance efforts. The shift to paperless validation is a strategic move necessary for modern life sciences companies to boost their efficiency and continue aligning with constantly evolving regulatory demands. The FDA's draft guidance on Computer Software Assurance and ISPE's GAMP 5 Second Edition both signal a shift to agile and risk-based validation methodologies, a clear indication for life sciences organizations to start embracing digital tools for improved efficiency, accuracy, and compliance. Our in-depth analysis explores the transition from the paper-based validation methods that have been used for decades to modern digital tools, covering everything from compliance with 21 CFR Part 11, EU Annex 11, and global standards in GxP environments to manufacturing, as well as key essentials such as the long-term benefits of switching to paperless validation. Still in doubt or want to learn more? Download our comprehensive in depth analysis to gain deeper insights into best practices and key implementation steps, and see how PQE Group is helping leading life sciences companies leverage paperless validation to drive innovation and efficiency while ensuring regulatory compliance in the real world. ## **AI in the QMS: The Regulatory Obligations Many Teams Overlook** Most of the conversation centers on AI as the product. However, many manufacturers are also adopting AI in daily workflows. Some examples include: drafting documentation, analyzing complaints, supporting CAPA triage, generating test cases, assisting literature reviews. Since FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026, which aligned 21 CFR Part 820 with ISO 13485:2016, software used in production or the quality system must be validated for its intended use. FDA’s updated [Computer Software Assurance guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software) (February 2026) frames this in risk-based terms, and that thinking extends naturally to AI tools. Two common scenarios sit on opposite sides of the same problem: - Ungoverned adoption: AI tools touching quality records without a documented intended use, assurance rationale, or human oversight. This is an audit finding waiting to happen; and - Paralysis: teams forgoing meaningful efficiency gains because no one has defined what “enough” assurance looks like. Both are solvable, and the answer in each case depends on how much the tool influences decisions about product safety and quality. ## **Questions Leaders Should be Asking Now** As AI-enabled devices become increasingly dynamic, manufacturers should assess whether their quality and regulatory strategies are positioned to support future change. If your team plans to update its algorithm over time, can you clearly identify which modifications could be implemented without a new submission and demonstrate that those changes remain within established regulatory boundaries? Is your PCCP, or planned PCCP, specific enough to be objectively verified while still providing meaningful flexibility for future improvements? Equally important, are your underlying processes capable of delivering on that strategy? A PCCP is only as strong as the quality system that supports it. Design controls, data governance, risk management, verification and validation activities, and post-market surveillance processes must all be capable of executing the commitments made to regulators. Organizations should also consider how they will monitor real-world performance, detect algorithm drift or changing clinical conditions, and ensure that responsibility for responding to those signals is clearly defined. Finally, manufacturers should look beyond the AI embedded in their products and examine the AI tools increasingly being adopted across their organizations. What AI-enabled tools are being used to support quality, regulatory, engineering, or clinical activities? Is their intended use documented? Is appropriate oversight in place? And for organizations marketing products in both the United States and Europe, are they building a single, integrated body of documentation and evidence, or creating parallel compliance efforts that will become increasingly difficult to maintain over time? If these questions are difficult to answer with confidence now is the time to address them, long before they arise during a regulatory review, inspection, or audit.   *Disclaimer: This article is for general informational purposes only. Regulatory requirements and guidance documents in this area are evolving quickly. Confirm current regulatory requirements and guidance documents with the relevant authorities and qualified advisors before making decisions. Information reflects publicly available sources as of October 2026.*   ![AI-Enabled Device\_Blog](https://blog.pqegroup.com/hs-fs/hubfs/AI-Enabled%20Device_Blog.webp?width=2000&name=AI-Enabled%20Device_Blog.webp) ## Want to know more? Our consultants can support you to achieve the full compliance of your products. Visit our **[Quality Compliance](https://www2.pqegroup.com/quality-compliance/)** dedicated page or get in touch with us to learn how PQE Group can help your business. 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