Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved modifications without submitting a 510(k) or PMA supplement for each change. By leveraging PCCPs, manufacturers can increase efficiency, accelerate innovation, and allocate resources more strategically. But what are PCCPs and how can companies benefit from this streamlined regulatory approach?

The Draft Guidance on Predetermined Change Control Plans for Medical Devices (issued August 22, 2024) and the Final Guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (issued December 4, 2024) expand the scope of PCCPs and provide clear recommendations for their integration into submissions. This alert highlights the key elements of these guidances, examines the benefits and challenges of PCCPs, and offers insights to help companies evaluate whether their device is a good candidate for a PCCP.

What is a Predetermined Change Control Plan or “PCCP”?

A PCCP allows manufacturers to include a detailed plan for future device changes within a 510(k), PMA, or De Novo submission. Once approved by the FDA, the PCCP allows manufacturers to implement these pre-approved changes without requiring additional FDA submissions, as long as the changes align with the plan.

Key Highlights from the Draft Guidance on PCCPs for Medical Devices

FDA’s Draft Guidance on Predetermined Change Control Plans for Medical Devices (issued August 22, 2024) outlines FDA’s approach to medical device PCCPs.

Purpose of PCCPs

The purpose of a PCCP is to establish a regulatory framework that enables medical device manufacturers to pre-define and secure FDA approval for specific, anticipated changes to their devices. By streamlining the regulatory process and minimizing delays, PCCPs allow manufacturers to implement updates and improvements more efficiently while maintaining safety and effectiveness.

Components of a PCCP

The FDA guidance documents describe the three main components of a PCCP:

1. The Description of Modifications should contain a detailed outline of planned changes, such as updates to device design, software, or materials.
2. The Modification Protocol should include documentation of the validation and verification activities to be performed to ensure safety and effectiveness.
3. The Impact Assessment contains a risk-benefit analysis to evaluate how changes will impact the device and mitigate potential risks.

Types of Changes that are Appropriate for PCCPs:

• Changes in device design, such as dimensions, performance specifications, or wireless communication.
• Updates to sterilization, packaging, transport, or expiration dating using established methods.
• Adjustments to materials or components, like substituting raw materials or hardware.
• Software modifications to enhance compatibility, interoperability, or performance.
• Labeling changes to specify subpopulations or additional use scenarios.
• Indication changes allowing the device to be used in home settings.

Changes Generally Not Appropriate for PCCPs:

• Changes to the device’s control mechanism, operating principle, or intended use.
• Transitioning from single-use to reusable labeling.
• Alterations to contraindications, prescription status, or patient population.
• Changes requiring new clinical data or addressing recalls or safety issues.

Submission Process

PCCPs can be included in initial submissions or proposed later through supplements, providing flexibility for manufacturers to adapt their regulatory strategy as their products evolve. Manufacturers can also submit to FDA to propose changes to an existing PCCP.

PCCPs for AI-Enabled Device Software Functions (AI-DSFs):

FDA’s Final Guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (issued December 4, 2024) recognizes the iterative nature of AI technologies. It provides recommendations for incorporating PCCPs into AI-DSF submissions. For example, the PCCP should describe the planned AI-DSF changes, the associated methodology to develop, validate, and implement those changes, and an assessment of the impact of those changes. FDA reviews the PCCP as part of a submission to ensure the safety and effectiveness of the device without requiring additional submissions for implementing each change described in the PCCP.

Benefits of PCCPs

PCCPs offer numerous advantages, including:

• PCCPs offer the potential to streamline regulatory approvals
  • Implement pre-approved modifications without delays.
  • Eliminate repetitive marketing submissions.
  • Focus on product development with reduced uncertainty.

• Support innovation
  • Keep pace with advancements, especially for AI-enabled devices.
  • Invest confidently in new technologies with pre-planned updates.
  • Enhance device safety and performance in real time.

• Enhance market agility
  • Respond quickly to changing market demands and technological advancements.
  • Address potential risks early with pre-approved plans.
  • Demonstrate commitment to quality with timely updates.

• Optimize resource allocation
  • Redirect efforts toward innovation and customer engagement.
  • Streamline processes for regulatory and development teams.

• Regulatory alignment
  • Establish a solid framework with FDA in advance for managing device updates over time.
  • Support modifications across an expanding product portfolio.

Challenges with PCCPs

While PCCPs provide regulatory benefits, developing and implementing them is not without challenges. Manufacturers must navigate complex FDA requirements, develop precise change plans, and establish robust validation and risk assessment protocols in advance. Coordinating input from multiple teams and integrating the PCCP into the company’s quality management system (QMS) adds further complexity. For AI-enabled devices, continuous monitoring and iterative updates introduce additional layers of difficulty. These processes require significant time, resources, and expertise.

Are Companies Using PCCPs?

Yes, though adoption remains in its early stages. Recently, there has been an increase in the use of PCCPs, primarily for 510(k)-cleared devices. A review of FDA’s medical device database (spanning back to 1976) reveals that 67 devices have received FDA-authorized PCCPs, broken down as follows:

Submission Type	# of PCCPs
510(k)	59
De Novo	3
PMA	5

Interestingly, the majority of these PCCPs (59 out of 67) were authorized within the last two years, reflecting a recent shift toward utilizing this regulatory mechanism.

To provide context, the FDA cleared over 3,000 510(k) submissions in 2024, but only 41 of those included PCCPs. PCCPs were utilized in approximately 1% of all 510(k) submissions in 2024.

Despite their limited use so far, we anticipate increased adoption of PCCPs in the coming years as manufacturers become more familiar with their benefits and incorporate them early on into their regulatory strategies. Their usefulness will also increase within a product’s own lifetime as experience with device changes leads to increased utility of PCCPs.

Strategic Planning for PCCP Success

Although PCCPs streamline the regulatory process and support innovation, developing a compliant PCCP requires thoughtful planning. Manufacturers should first evaluate whether their planned device changes would qualify for inclusion in a PCCP, then prepare detailed plans for submission.

Amanda Johnston, Partner at Gardner Law, notes that the upfront effort of a well-designed PCCP may lead to time and resource savings in the long run. “To evaluate whether a PCCP is worthwhile, companies should assess the types of changes they expect to make over the device’s lifecycle. For instance, if updates to software, materials, or components are part of the roadmap, a PCCP may be a strategic choice. With FDA user fees reaching $24,355 for a 510(k) and $81,117 for a 180-Day PMA Supplement in FY2025, investing in a well-developed PCCP can lead to significant long-term cost and time savings by reducing the need for multiple submissions.”

Nathan Downing, Managing Attorney at Gardner Law, suggests the commercial team consider PCCPs as part of the overall market strategy. “PCCPs provide greater predictability in the timing of new functions and claims, and industry would be wise to take advantage of that opportunity.”

For assistance in drafting PCCPs or navigating these pathways, contact the Gardner Law team.