FDA Advances Predetermined Change Control Plans for Medical Devices

Regulatory Update | Medical Devices | October 2026

Medical devices are increasingly designed to evolve. Software gets updated, AI models are refined, performance improves, and new capabilities emerge after a device is already on the market.

For manufacturers, that raises a critical regulatory question:

When does a planned modification require a new submission to the U.S. Food and Drug Administration (FDA)?

The FDA is continuing to develop an approach that lets certain anticipated modifications be addressed in advance through Predetermined Change Control Plans (PCCPs). On 20 October 2026, the FDA's Center for Devices and Radiological Health (CDRH) published new information on PCCPs, along with hypothetical case examples involving novel medical devices.

For manufacturers of innovative, software-enabled, and AI-enabled devices, this is a chance to build a regulatory strategy not just for the device as it exists today, but for how it's expected to evolve.

What Is a Predetermined Change Control Plan?

A PCCP describes specific planned changes a manufacturer may make to a device, along with the methods it will use to develop, test, and implement those changes and assess their impact.

A PCCP can be submitted as part of a marketing submission. If the FDA authorises it, the manufacturer may make the specified future modifications without a new marketing submission for each change, provided the changes stay within the authorised PCCP and follow its requirements.

Why This Matters

Traditionally, when a manufacturer changes an authorised device, it must determine whether the modification needs a new or supplemental submission, depending on the change and the applicable pathway.

A PCCP flips that approach for certain planned modifications: instead of waiting until a change is proposed, manufacturers can seek FDA authorisation for specified future changes upfront. This brings greater predictability for technologies expected to evolve.

The FDA notes PCCPs may help planned improvements reach patients faster while still addressing safety and effectiveness and may reduce the number of additional submissions needed.

What Can a PCCP Cover?

A PCCP can address planned modifications that would otherwise require a new marketing submission, as long as the changes remain within the device's intended use. For 510(k) devices, the modified device must also remain substantially equivalent to the predicate.

PCCPs can be included in submissions through several FDA pathways:

• 510(k)

• De Novo

• Premarket Approval (PMA)

  
  

They may also apply to certain device-led combination products.

What Does a PCCP Include?

According to the FDA, a PCCP generally has three components:

Component	What It Covers
1. Description of Modifications	The changes the manufacturer anticipates including device characteristics, performance, or specifications with clear boundaries
2. Modification Protocol	How each change will be developed, evaluated, and implemented, including performance evaluation, predefined acceptance criteria, and (where applicable) how users will be informed
3. Impact Assessment	The individual and cumulative impact of the changes: benefits and risks, interactions between modifications, and whether the overall approach continues to ensure safety and effectiveness

A PCCP is more than a list of future improvements. It's a regulatory framework for managing the planned evolution of a device.

FDA's New Hypothetical Examples

The October 2026 update includes hypothetical examples showing how PCCPs could work for novel devices. One describes a machine-learning device that continuously analyses structured patient data to produce a sepsis risk score and dashboard alert for clinicians.

The example shows how a PCCP could accommodate site-specific adaptations using historical data from individual hospital systems as long as they stay within the authorised scope and meet predefined acceptance criteria.

This is especially relevant for AI-enabled and software-driven technologies: rather than assuming a device stays static after authorisation, regulatory strategy can anticipate certain types of controlled evolution.

PCCPs and AI-Enabled Medical Devices

AI-enabled products can evolve through changes to algorithms, data inputs, performance characteristics, and other software components. The FDA has already developed PCCP-specific guidance for AI-enabled device software functions, including recommendations published in August 2025.

For AI-enabled devices, regulatory planning should ask not only "What is the device today?" but also:

"What changes do we reasonably expect this device to undergo?"

What This Means for Manufacturers

Regulatory strategy should begin earlier. Consider future changes during product development, not after authorisation. Manufacturers can incorporate reasonably anticipated modifications into a PCCP strategy.

Product development and regulatory affairs must work together. A PCCP requires detailed knowledge of planned modifications, testing methods, acceptance criteria, and safety impact, so regulatory teams need close coordination with R&D, software, quality, clinical, data science/AI, and product management.

Scope must be clearly defined. A PCCP doesn't provide unlimited flexibility. Future modifications must stay within the authorised scope and follow the approved procedures.

Evidence planning becomes more important. Because a PCCP includes performance evaluation and predefined acceptance criteria, you'll need to plan how future changes will be tested and validated, which can shape development and evidence strategies from an early stage.

What Companies Should Do Now

1. Identify anticipated device changes, including planned performance improvements, software modifications, or other controlled updates.

2. Assess whether a PCCP is appropriate: not every device or modification needs one; consider whether it would provide a meaningful regulatory advantage.

3. Define modification boundaries clear limits for each planned change help show it stays within the authorised framework.

4. Develop testing and acceptance criteria decide how each change will be evaluated and what will demonstrate continued safety and effectiveness.

5. Assess cumulative changes: look at the combined effect of multiple modifications, especially where one could influence another.

6. Align regulatory and product roadmaps: if you know a device will evolve significantly, factor that into your initial submission strategy.

   
   

Why This Matters for International Manufacturers

Companies outside the U.S. often coordinate development, submissions, and post-market changes across multiple jurisdictions. A modification that's straightforward in one market may trigger a different assessment elsewhere, so the regulatory implications of product evolution need to be understood across markets, not treated as isolated technical matters.

For manufacturers planning U.S. entry, PCCPs can form part of a broader strategy:

Initial Submission → Authorisation → Planned Modifications → Evidence Generation → Implementation → Ongoing Compliance

ARQon Insight

The FDA's work on PCCPs reflects a broader shift: regulatory strategy increasingly needs to account for how products will evolve, not just how they enter the market.

Devices are becoming more software-driven, connected, and adaptable. For some, improvement after authorisation isn't an exception; it's part of the expected lifecycle. PCCPs give manufacturers a way to plan for certain future changes while keeping FDA oversight of the approach.

For innovators, the strategic question becomes:

Can we anticipate the evolution of our product early enough to build a regulatory pathway around it?

The answer can influence development timelines, evidence planning, and the efficiency of future modifications.

Regulatory Intelligence Is Part of Product Strategy

Integrate regulatory intelligence into product development from the start. Monitor not just new regulations, but also:

• FDA guidance and CDRH updates

• New regulatory pathways

• Examples of authorised PCCPs

• AI-related regulatory developments

• Changes in submission expectations

• Emerging approaches to software-enabled devices

  
  

Understanding how regulators are adapting to new technologies helps companies make better decisions before their products reach submission.

Key Takeaway

On 20 October 2026, the FDA published new information on Predetermined Change Control Plans, with hypothetical examples for novel devices. A PCCP can let manufacturers seek authorisation for certain planned future modifications as part of the marketing submission, potentially avoiding a separate submission for every change that stays within the authorised plan.

For manufacturers of innovative, software-enabled, and AI-enabled devices, it's an important strategy to consider.

The future of a medical device should be part of its regulatory strategy today.

How ARQon Can Support You

ARQon supports healthcare and life-science companies with regulatory intelligence and market-access activities across international markets, including:

• Regulatory intelligence and monitoring

• U.S. market-entry strategy

• Medical-device regulatory pathway assessment

• Regulatory gap analysis

• Submission strategy

• Product classification and pathway assessment

• AI and software-enabled medical-device regulatory intelligence

• Change-management and post-market regulatory planning

• Cross-border market-access strategy

  
  

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.

Sources

U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH):

• Predetermined Change Control Plans, updated October 2026

• Novel Medical Devices with Predetermined Change Control Plans: Hypothetical Case Examples, October 2026

• CDRH New – News and Updates, 20 October 2026