FDA Predetermined Change Control Plan (PCCP): Compliance Guide

FDA Predetermined Change Control Plan (PCCP): Compliance Guide

Lee Chickering and • 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In April of 2023, the FDA published the draft guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 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)?

.png)

Sourced from Ketryx's webinar, "Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path"

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. 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 FDA has designated the acronym ML-DSF (machine learning-enabled device software function) to describe this specific AI use in the medical industry.

The focus on ML-DSF and the adoption of approaches like the PCCP represent a pivotal shift in the regulatory paradigm, fostering innovation and efficiency while maintaining the high standards of safety and efficacy in medical device development.

Artificial intelligence (AI) and more specifically machine learning (ML) is a new and powerful tool companies around the world are beginning to integrate into their medical device systems in order to be more efficient and productive. The FDA recognizes the importance of AI/ML in the medical industry and is trying to create a process to allow companies to develop safe and effective medical devices that use ML models developed with ML algorithms.

How to Create a PCCP

The PCCP draft guidance includes three main sections:

PCCP Description of Modifications

Purpose of a Description of Modifications

This section describes each planned modification to an ML-DSF in the PCCP as either a stand-alone submission or in concert with a “new” premarket submission. For modifications to an approved PCCP, the FDA recommends that a PCCP include “only a limited number of modifications that are specific, and that can be verified and validated.”

How to Complete a Description of Modifications

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. 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).

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 modifications while ensuring continued device safety and effectiveness. The goals of the Modification Protocol include identifying the methods and data used to develop, validate, and implement all proposed modifications.

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 Impact Assessment is structured to:

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. A big mistake medical device companies make with regards to a new PCCP submission is thinking all they need to do is create a new process.

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.

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 along with an example product.