Innovation in medical devices and in vitro diagnostics (IVDs) has accelerated significantly, especially in the realm of artificial intelligence (AI) and machine learning (ML). To keep pace with technological advancements while maintaining safety and efficacy, regulatory frameworks must evolve. Predetermined Change Control Plans (PCCPs) represent one such advancement, offering a proactive, structured approach to regulatory change management. These plans allow pre-authorised, well-defined changes without requiring full re-submission, streamlining innovation while preserving oversight. Though not yet widely adopted, PCCPs have the potential to transform regulatory practice across device categories, extending well beyond AI-enabled systems.
Streamlining Innovation While Maintaining Oversight
PCCPs are designed to accelerate device improvement while upholding rigorous regulatory standards. At the time of initial device approval, manufacturers submit a detailed plan outlining the specific modifications they may implement post-approval. Once the plan is authorised, these changes can be made without the need for repeated submissions, allowing innovations to reach patients faster. This mechanism is particularly advantageous for AI/ML-enabled devices, where frequent updates—such as integrating new data sources—can refine performance for specific patient subpopulations.
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Rather than bypassing regulatory scrutiny, PCCPs consolidate it into a single, forward-looking review process. They ensure modifications are implemented within a predetermined and regulator-approved protocol, preserving transparency and accountability. Much like a city planning infrastructure upgrades in advance of expected growth, PCCPs establish the groundwork for safe, timely evolution of medical technologies. This balance of foresight and control enhances efficiency without compromising patient safety.
Preserving Device Integrity Within Defined Parameters
While PCCPs offer agility, they are not a mechanism for unrestricted change. A fundamental criterion is that the device's intended use must remain unchanged. For example, a software update that enhances a navigation system remains within scope, whereas transforming that same system into a fully autonomous function alters its purpose and thus exceeds PCCP boundaries. Similarly, a diagnostic imaging device cannot incorporate therapeutic capabilities under an existing PCCP, as this represents a shift in use rather than an evolution of functionality.
It is vital that all stakeholders understand that PCCPs are not loopholes. Each proposed change must be clearly defined, risk-assessed and documented within the plan. Regulators retain full authority to approve or reject these plans, ensuring each modification aligns with public health standards. If documentation is insufficient or overly complex in the premarket phase, the scope and value of the PCCP may be limited. Regulatory bodies must strike a balance between enabling adaptive change management and enforcing thorough, transparent documentation requirements.
Widening Application Beyond AI/ML Devices
Although PCCPs were initially conceptualised to address the rapid evolution of AI/ML devices, their potential extends across the broader landscape of medical technology. As of mid-2024, approximately 950 AI/ML devices had been authorised for use in the United States, a fraction compared to nearly 6,000 traditional devices. Applying PCCPs only to AI/ML devices risks missing opportunities to streamline improvements in the much larger segment of conventional medical technologies.
Positive regulatory developments, such as the FDA’s draft guidance for PCCPs, suggest an intent to broaden the application of these plans. Emphasising cross-device utility allows PCCPs to serve as a universal mechanism to support innovation while managing regulatory workload. By extending PCCPs to traditional devices and IVDs, regulators and manufacturers can more effectively allocate resources, accelerate access to advancements and avoid unnecessary delays in patient care.
Predetermined Change Control Plans present a strategic regulatory tool for enabling continuous innovation in medical devices and IVDs. By pre-authorising specific changes, PCCPs reduce the time and administrative burden associated with post-approval modifications, particularly in rapidly evolving domains like AI/ML. Crucially, PCCPs are grounded in rigorous planning and regulatory approval, ensuring that safety and efficacy remain paramount. Their value lies not only in expediting innovation but in fostering greater collaboration between stakeholders—manufacturers, regulators and patients. As regulatory frameworks adapt to the demands of modern healthcare, broader adoption and harmonisation of PCCPs will be essential to unlocking the full potential of medical technology advancement.
Source: Healthcare Transformers
Image Credit: iStock
