By Daniel Simpson, RAC, Director of Regulatory Affairs, DCN Dx
Introduction
The U.S. Food and Drug Administration (FDA) has introduced a transformative regulatory framework known as FDA Predetermined Change Control Plans (PCCPs), designed to streamline the approval and implementation of software modifications in artificial intelligence (AI)-enabled medical devices which include IVDs. This framework addresses the unique challenges posed by the iterative nature of AI development and offers a pathway for continuous innovation while maintaining safety and effectiveness. Recent draft guidance suggests that PCCPs may soon be applicable to all medical devices, signaling a significant shift in regulatory strategy.
1. Background and Regulatory Context
1.1 Origin of FDA Predetermined Change Control Plans
PCCPs were formally authorized under Section 515C of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Omnibus Reform Act (FDORA) of 2022. This provision allows manufacturers to include a PCCP in their initial marketing submission, enabling pre-approved modifications without requiring supplemental submissions.
1.2 AI-Specific Guidance
In December 2024, FDA finalized its guidance document titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” (reissued August 18, 2025). This guidance outlines how manufacturers can structure PCCPs for AI-enabled device software functions (AI-DSFs). In this guidance, FDA affirms its commitment to applying innovative approaches to regulating medical device software and other digital health technologies while maintaining safety and effectiveness. The concept of PCCPs was introduced in FDA’s April 2019 discussion paper on a proposed regulatory framework for modifications to AI/ML-based Software as a Medical Device (SaMD). That paper recognized the need for flexibility in the marketing authorization process due to the iterative nature of these products. The FDA Predetermined Change Control Plans framework has continued to evolve through industry feedback, including comments submitted on the 2019 discussion paper and discussions in public workshops on the topic.
2. PCCP Structure and Components
A PCCP includes those device modifications that generally would otherwise require a new marketing submission such as a 510(k), De Novo, or PMA. These modifications include those that could significantly affect, or that otherwise affect, the safety or effectiveness of the device, unless these changes are validated in a PCCP. Therefore, in a PCCP, a manufacturer can prospectively specify and seek FDA clearance or approval for intended modifications to an AI-IVD without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such modifications, provided the changes are implemented consistent with the PCCP that has been reviewed and established through a device marketing authorization.
A PCCP must include three core elements:
- Description of Modifications: Clearly defines the scope and nature of anticipated changes.
- Modification Protocol: Details the methods for developing, verifying, validating, and implementing changes. The modification protocol must contain pre-defined acceptance criteria.
- Impact Assessment: Evaluates the risks and benefits of the proposed modifications. These components ensure that updates remain within the bounds of safety and effectiveness, allowing for regulatory flexibility without compromising patient outcomes.
PCCPs are included in marketing submissions as standalone sections/documents with a title and version number and are ideally a part of the manufacturer’s Design History File documentation. In some cases, the labeling of the IVD device may require mention of the PCCP and the PCCP must be mentioned in publicly available submission summaries such as 510(k) summaries.
The PCCP, once approved by FDA along with the marketing submission, should be incorporated into the manufacturer’s risk management process and Quality Management System (QMS) to ensure that the PCCP is followed as per the requirements outlined in the marketing submission. Results of the modification protocol and associated validations should be incorporated into all manufacturing and test procedures. Failure to incorporate a required PCCP could result in enforcement actions during FDA inspections.
Modifications to a PCCP constitute a potential new marketing submission and it is recommended that manufacturers discuss modifications with FDA using the Pre-Sub process.
3. Implications for IVD Manufacturers with AI-Enabled Devices
As with any regulatory framework PCCPs come with potential benefits but also can present challenges to manufacturers, regulators, and IVD stakeholders.
3.1 Benefits
- Accelerated Innovation: Enables rapid deployment of algorithmic improvements.
- Regulatory Efficiency: Reduces the need for repeated submissions.
- Cost Savings: Minimizes expenses associated with supplemental applications.
- Improved Patient Care: Facilitates timely enhancements to diagnostic and therapeutic capabilities.
3.2 Challenges
- Documentation Burden: Requires detailed upfront planning and validation protocols.
- Quality System Integration: Manufacturers must maintain robust systems to track and implement changes.
- Scope Limitations: Modifications must align strictly with the approved PCCP; deviations require new submissions.
4. Expansion of PCCPs to All Medical Devices
Upon creation of the PCCP concept, both FDA and industry recognized its value in all medical device marketing submissions to reduce the need for future market submissions due to foreseen changes in the medical device.
4.1 Draft Guidance Overview
In August 2024, the FDA released a draft guidance titled “Predetermined Change Control Plans for Medical Devices”, extending the PCCP framework beyond AI-enabled devices to all device types, including device-led combination products.
4.2 Key Concepts in Expanding FDA Predetermined Change Control Plans to all Device Types
- PCCPs can be submitted with 510(k), De Novo, or PMA applications. However, to accept the use of the PCCP in the marketing authorization, the manufacturer must provide reasonable assurance of safety and effectiveness.
- The guidance outlines acceptable modification types, including hardware changes, raw material modifications, and software updates. Generally, the modifications should not significantly affect the safety and effectiveness of the device.
- PCCPs must maintain the device’s intended use and ensure substantial equivalence or safety and effectiveness. Additionally, PCCPs must be in harmony with existing device modification guidance documents.
4.3 Strategic Implications
The broader adoption of FDA Predetermined Change Control Plans encourages proactive change management across the industry.
- Cybersecurity and Connectivity: Supports timely updates for connected devices.
- Regulatory Harmonization: Aligns with global efforts to modernize device regulation (e.g., GMLP principles).
5. Outlook and Recommendations
5.1 Industry Impact
The expansion of FDA Predetermined Change Control Plans represents a paradigm shift in medical device regulation. It empowers manufacturers to innovate responsibly while reducing regulatory friction.
5.2 Recommendations for Manufacturers
As stated above, PCCPs can be a powerful tool for IVD manufacturers to use for both AI submissions and potentially any marketing submission. Below are recommendations on how to successfully implement PCCPs into regulatory and QMS processes.
- PCCPs should be built into a manufacturer’s Design Control process to be considered early in development. Procedures should be in place to identify potential modifications that could be incorporated into a PCCP.
- If a manufacturer identifies the potential to use a PCCP framework to address potential modifications, early engagement with FDA using the Pre-Sub process is recommended.
- Manufacturers should ensure that their QMS systems support the operational aspects of a PCCP to ensure the PCCPs are executed per requirements.
Conclusion
The FDA Predetermined Change Control Plans framework is a forward-looking regulatory tool that balances innovation with patient safety. While initially focused on AI-enabled devices, its potential application to all medical devices could redefine how manufacturers approach product lifecycle management. Stakeholders should prepare for this evolution by adopting proactive strategies and engaging with regulators to ensure compliance and competitiveness.
DCN Dx’s Regulatory Affairs Services help IVD teams develop successful regulatory plans and submissions. We support FDA pathways including 510(k), De Novo, and PMA, with early Pre-Sub positioning and submission development, and we can advise on accelerated programs like Breakthrough Devices and STeP when they fit the product. Our team aligns verification and validation expectations across software and cybersecurity, biocompatibility, labeling, shelf life, analytical and clinical performance, usability and human factors, and CLIA waiver flex studies. We also support QMS readiness (ISO 13485, CLIA, CAP) and post-market obligations. For more information, visit our Regulatory Affairs page.
