On October 20, 2026, the FDA published new hypothetical case examples demonstrating how Predetermined Change Control Plans (PCCPs) can support modifications to medical devices, including devices that use machine learning and continuously evolving software.

The examples illustrate an important opportunity for manufacturers: certain future device modifications can be reviewed and authorized in advance, potentially eliminating the need for a separate marketing submission each time an approved modification is implemented.

For medical device and combination product teams, the takeaway is clear: change control should begin long before a change is implemented.

What FDA Is Signaling

A Predetermined Change Control Plan (PCCP) allows manufacturers to identify specific future modifications, establish how those changes will be developed and validated, and assess their potential impact on device safety and effectiveness.

FDA identifies three essential components:

• Description of Modifications: What changes are planned and their defined boundaries.
• Modification Protocol: How changes will be developed, verified, validated, and implemented, including predefined acceptance criteria.
• Impact Assessment: How modifications may affect device performance, safety, effectiveness, and one another.

When FDA authorizes a PCCP as part of a marketing submission, qualifying modifications can be implemented without a new submission, provided they remain within the authorized plan.

This flexibility, however, does not eliminate the manufacturer’s responsibility to maintain effective quality system controls.

What the New Examples Demonstrate

FDA’s newly published examples illustrate two different approaches to managing future modifications.

Hospital-Localized Sepsis Alert System

The first hypothetical example describes a machine learning system that identifies patients at risk of developing sepsis.

A PCCP could permit adjustments to the system using hospital-specific patient data, including changes to model parameters and alert thresholds.

However, these modifications would require defined data quality requirements, performance validation, documentation, controlled deployment, and postmarket monitoring.

Continuously Learning Cardiac Arrhythmia Detection Software

The second example involves software that periodically retrains its model using newly collected cardiac monitoring data.

FDA describes how automated modifications could occur within a predefined framework, including acceptence criteria, deployment controls, audit trails, and ongoing performance monitoring.

Importantly, the hypothetical process includes mechanisms to block deployment when validation criteria are not met.

Both examples reinforce that regulatory flexibility depends on demonstrating control over the modification process.

Why This Matters for Quality Systems

PCCPs are not simply regulatory documents. Successful implementation requires alignment between regulatory affairs, quality assurance, engineering, software development, and postmarket surveillance.

Manufacturers need processes capable of demonstrating that modifications remain within their authorized scope and continue to meet established performance requirements.

This includes:

• Design controls: Maintaining traceability between requirements, modifications, risk assessments, and verification and validation activities.
• Change control: Ensuring proposed modifications are reviewed against the authorized PCCP before implementation.
• Risk management: Evaluating individual and cumulative impacts of modifications, including unintended consequences.
• Validation: Establishing objective acceptance criteria and documenting evidence that modifications meet them.
• Document control: Maintaining accurate revision histories, technical documentation, labeling, and approval records.
• Postmarket monitoring: Detecting performance changes, emerging risks, and potential issues following deployment.

The underlying principle is familiar: a well-controlled process should produce documented evidence that supports the manufacturer’s decisions.

What Manufacturers Should Do Now

Even organizations that are not currently pursuing a PCCP can benefit from evaluating how future modifications are planned and controlled.

1. Identify foreseeable modifications. Consider which product updates, software changes, or performance improvements are likely during the device lifecycle.

2. Evaluate PCCP eligibility. Determine whether anticipated modifications may qualify for inclusion in a PCCP and whether the approach aligns with the device’s regulatory pathway.

3. Define verification and validation expectations early. Establish acceptance criteria, testing methods, and evidence requirements before modifications are implemented.

4. Strengthen cross-functional change control. Ensure regulatory, quality, engineering, and risk management teams understand their responsibilities throughout the modification process.

5. Build postmarket monitoring into the strategy. Determine how the organization will identify unexpected performance changes and respond when outcomes fall outside established limits.

Bottom Line

FDA’s new PCCP examples highlight an important development in medical device regulation: manufacturers may have greater flexibility to implement planned improvements, but that flexibility depends on disciplined risk management, validation, and quality oversight.

The goal is not just tto make changes faster. It is to make changes predictably, safely, and with the documentation needed to demonstrate continued regulatory compliance.

For manufacturers considering PCCPs or strengthening existing change control processes, early planning can help reduce regulatory uncertainty, prevent rework, and support a more efficient product lifecycle.

Quality Solutions Now (QSN) supports medical device and combination product manufacturers with design controls, risk management, validation, quality system implementation, remediation, and regulatory readiness. Our team can help organizations evaluate their change control processes and build the documentation and oversight needed to support controlled product modifications.