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
- What is a Predetermined Change Control Plan (PCCP)?
- How to Create a PCCP
- PCCP Description of Modifications
- PCCP Modification Protocol
- PCCP Impact Assessment
- What Do Medical Device Companies Need to Know About PCCP Submissions?
- How Ketryx Can Help Manufacturers & Developers with their PCCP
- FDA Predetermined Change Control Plan (PCCP) Template
In April of 2023, the FDA published the draft guidance “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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)?
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. This 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 flexibility to adapt and enhance without excessive bureaucratic hurdles is pivotal in enabling advancements in medical device technology.
The FDA has designated the acronym ML-DSF (machine learning-enabled device software function) to describe this specific AI use in the medical industry.
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The PCCP draft guidance includes three main sections: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. 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 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. This focused approach enables thorough scrutiny and assessment of each modification's impact on the device's performance, safety, and effectiveness.
The Description of Modifications should itemize the proposed device modifications, along with specific justifications for the ML-DSF modifications. Additionally, it should indicate if the modifications are automatic (implemented by software) or manual (requiring human intervention). This distinction becomes crucial in the FDA's assessment, especially concerning the substantial equivalence or safety and effectiveness of the modifications.
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 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.
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 information that would otherwise be generated and submitted to the Agency will be generated by the manufacturer for each modification and maintained consistent with recordkeeping requirements and in compliance with the manufacturer’s QMS
- Ensuring that the risks identified in the Impact Assessment related to modifications will be mitigated
- Being least burdensome for the manufacturer to develop and for the FDA to review
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 (design control) 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. 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, which includes:
- A first-time PCCP approval
- Deviations from an approved PCCP
- Significant impacts on the device’s safety and effectiveness from ML-DSF modifications or protocol changes
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. Ketryx also automatically updates traceability and supports users in creating engineering controls to ensure compliance with their PCCP.
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 components of the PCCP along with an example product, designed for companies to replace text with their company-specific information.