FDA Predetermined Change Control Plan (PCCP): Compliance Guide

Lee Chickering

May 9, 2024

Table of Contents

In April of 2023, the FDA published the draft guidance “ Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” In this preliminary guidance, the FDA presented a forward-thinking strategy rooted in scientific principles to guarantee the safe, efficient, and swift adaptation, enhancement, and refinement of AI/ML-powered devices.

Although all of this all sounds intimidating, our goal is to break down the most significant parts of the Predetermined Change Control Plan (PCCP) for manufacturers to better understand this complex guidance.

What is a Predetermined Change Control Plan (PCCP)?

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The Predetermined Change Control Plan (PCCP) is an innovative approach to address ML-related risk in premarket submissions for medical devices. This plan empowers manufacturers to refine and tune AI/ML algorithms through frequent deployments within the constraints of safety and effectiveness without the need to make an additional premarket submission. What does this mean in practical terms? It translates to a significant reduction in time and resources required by manufacturers and regulators in preparing and reviewing premarket submissions for software changes.

The utilization of PCCP is meant to reduce regulatory burden by providing the means for real-time improvements in devices in the postmarket phase. The focus on ML-DSF and the adoption of approaches like the PCCP represents a pivotal shift in the regulatory paradigm, fostering innovation and efficiency while maintaining the high standards of safety and efficacy in medical device development.

How to Create a PCCP

The PCCP draft guidance includes three main sections:

  • Description of Modifications: Itemization of the proposed device modifications, along with specific justifications for the ML-DSF modifications.
  • Modification Protocol: Describes the means, methods, and manner to develop, validate, and implement these changes.
  • Impact Assessments: Entails documenting the evaluation of benefits and risks associated with implementing a PCCP for an ML-DSF, along with strategies to mitigate those risks.

PCCP Description of Modifications

Purpose of a Description of Modifications

This section is a description of each planned modification to an ML-DSF in the PCCP as either a stand-alone submission or in concert with a “new” premarket submission. Modifications to the PCCP that are difficult to verify and validate due to circumstances such as overly complex modifications, lack of specificity or clarity, or insufficient data or testing methods may impact the approval of the PCCP. By limiting the number of modifications, the FDA can concentrate their review efforts on a defined set of changes.

The Description of Modifications should itemize the proposed device modifications, along with specific justifications for the ML-DSF modifications. It is essential to indicate if the modifications are automatic (implemented by software) or manual (requiring human intervention). Additionally, it should specify whether modifications will be uniform across all devices or differ based on unique clinical site conditions or individual patient characteristics.

PCCP Modification Protocol

Purpose of Modification Protocol

The purpose of the Modification Protocol is to establish a comprehensive set of procedures delineating the step-by-step process for implementing the aforementioned modifications while ensuring continued device safety and effectiveness. This includes the documentation describing the methods that will be followed when developing, validating, and implementing modifications delineated in the Description of Modifications section of the PCCP.

How to Complete the Modification Protocol

The goals of the Modification Protocol include:

  • Identifying the methods and data used to develop, validate, and implement all proposed modifications.
  • Identifying the test methods, data, statistical analyses, and specified acceptance criteria for all proposed modifications.
  • Ensuring that the risks that have been identified in the Impact Assessment as related to modifications detailed in the Description of Modifications will be mitigated.

PCCP Impact Assessment

Purpose of the PCCP Impact Assessment

The Impact Assessment entails documenting the evaluation of benefits and risks associated with implementing a PCCP for an ML-DSF, along with strategies to mitigate those risks. The manufacturer conducts this assessment within the existing quality system framework.

How to Complete the PCCP Impact Assessment

Manufacturers should document how individual modifications affect not only the ML-DSF but also the device's overall functionality, including other software functions and hardware. Additionally, for combination products, documentation should address how device modifications in the PCCP impact the biologic/drug component and overall product.

What Do Medical Device Companies Need to Know About PCCP Submissions?

The PCCP process involves a periodic regulatory review of the manufacturer’s plan for maintaining the safety and effectiveness of a device, including a first-time PCCP approval, deviations from an approved PCCP, and when ML-DSF modifications or protocol changes significantly impact the device’s safety and effectiveness.

How Ketryx Can Help Manufacturers & Developers with their PCCP

Ketryx helps companies release software faster and in accordance with their PCCP by enabling developers to utilize modern development tools and practices while equipping quality teams with automated documentation and testing. Our team empowers manufacturers to use the tools that are utilized by software professionals to develop and update software.

FDA Predetermined Change Control Plan (PCCP) Template

Ketryx has built an in-depth PCCP template for manufacturers and companies looking to produce an FDA-compliant PCCP. This template explains the step-by-step instructions and procedures for each of the three components of the PCCP (Description of Modifications, Modification Protocol, Impact Assessment) along with an example product.