Guidance Breakdown: Predetermined Change Control Plans (PCCPs) for Medical Devices

The FDA issued new draft guidance proposing a policy for PCCPs and the information to include in a marketing submission for a device. We break it down.

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The FDA's new draft guidance on Predetermined Change Control Plans (PCCPs) for medical devices outlines the processes and protocols for including PCCPs in marketing submissions for medical devices. This guidance, issued on August 22, is part of the FDA's efforts to streamline the implementation of certain modifications to medical devices without requiring additional marketing submissions.

PCCPs allow manufacturers to prospectively specify and seek premarket authorization for intended modifications to a device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such modifications — provided the changes are implemented consistent with the authorized PCCP.

This guidance primarily impacts medical device manufacturers, regulatory professionals, and anyone involved in developing and modifying medical devices.

We break it down below.

Introduction and background

The guidance provides recommendations on developing and implementing PCCPs, including what types of modifications may be appropriate for inclusion in a PCCP and what information should be included in a PCCP submitted as part of a marketing submission. This approach aims to reduce regulatory burden while maintaining safety and effectiveness standards.

PCCPs were introduced in 2019 for AI/ML-based software modifications. The agency has continued to use the term in guidance on specific devices, including it in another AI-focused document and a text on antimicrobial susceptibility tests in 2023. This guidance expands the concept to all medical devices.

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Congress gave the FDA power to clear or approve PCCPs in a 2022 omnibus spending bill. Genetic testing company 23andMe entered into a PCCP with the FDA one year ago. 

However, the FDA has lacked broader guidance on how PCCPs apply to medical devices in general. The new draft guidance addresses that gap. In the draft, the FDA sets out its PCCP guiding principles and policy, describes the type of modifications eligible for the plans and lists the content to include in filings. 

Importantly, this guidance applies to the device constituent part of device-led combination products but does not apply to the drug or biologic constituent parts.

Types of modifications appropriate for PCCPs

The guidance outlines the types of modifications that may be appropriate for inclusion in a PCCP:

1. Modifications that maintain or improve device safety and effectiveness

2. Specific modifications that can be verified and validated

3. Modifications that maintain the device's intended use

4. For 510(k) devices, modifications that maintain substantial equivalence to the predicate device

The guidance also provides examples of modifications that may be appropriate for PCCPs, such as:

• Changes in device design (e.g., dimensions, performance specifications)

• Changes in sterilization, packaging, or expiration dating using well-established methods

• Certain changes in materials or components

• Software updates for compatibility or performance improvement

For 510(k) devices, the guidance recommends a risk-based assessment to determine if a modification is appropriate for a PCCP. Modifications that could introduce new risks are generally not appropriate, while those that could significantly modify existing risks may be appropriate if adequately mitigated by the existing risk management framework and quality system.

For PMA devices, minor changes and manufacturing changes may be appropriate for PCCPs if the risks are adequately mitigated.

Modifications generally not appropriate for PCCPs include:

• Changes to device control mechanisms or operating principles

• Changes that alter the intended use

• Changes from single-use to reusable

• Changes to address safety issues or recalls

• Addition of new patient populations

• Changes that may need new clinical data (with some exceptions for IVDs)

PCCP components

The guidance outlines three main components of a PCCP:

1. Description of Modifications: A detailed outline of the specific, planned modifications to the device. This should include specifications for the characteristics and performance of the device following the modifications.

2. Modification Protocol: Documentation describing the methods for developing, validating, and implementing the modifications, including verification and validation activities. This should include:

   • Performance evaluation methods

   • Pre-defined acceptance criteria

   • Update procedures, including plans for communication and user training

   • Post-market surveillance plans

3. Impact Assessment: An evaluation of the benefits and risks of implementing the PCCP, including how the modifications impact the overall device functionality. This should compare the device with each modification implemented individually to the unmodified version and discuss the cumulative impact of all modifications.

The guidance emphasizes the importance of traceability between these components, suggesting the use of a traceability table to map each modification to its corresponding performance evaluation methods and update procedures.

Establishing and implementing a PCCP

PCCPs can be established through various submission types, including:

• Original PMA applications

• PMA supplements (180-day, 135-day, Panel Track, Real-Time)

• Traditional and Abbreviated 510(k) submissions

• Original De Novo requests

The guidance states that PCCPs should be included as a standalone section within the marketing submission and prominently discussed in the cover letter and table of contents. The PCCP should also be referenced in relevant sections of the submission, such as the device description and labeling.

When implementing modifications under an authorized PCCP, manufacturers must follow their quality system requirements and update device labeling as specified in the PCCP. The guidance provides specific recommendations for labeling updates, including:

• A statement that the device has an authorized PCCP

• A description of implemented modifications

• How modifications were implemented

• How users will be informed of modifications

FDA review process

The FDA will review the PCCP as part of a device's marketing submission. The agency may require interactive reviews as manufacturers gain experience with PCCPs. If deficiencies with the PCCP remain unresolved, the FDA may authorize the device upon withdrawal of the PCCP.

For 510(k) submissions, the PCCP is considered part of the device's technological characteristics in the substantial equivalence determination. The guidance specifies that in making a determination of substantial equivalence where the predicate device was authorized with a PCCP, the subject device must be compared to the version of the predicate device cleared or approved prior to changes made under the PCCP.

Modifying an authorized PCCP

Modifications to an authorized PCCP will generally require a new marketing submission. The FDA will focus its review on the aspects of the device that are most significantly modified. The guidance recommends providing a summary of changes to the authorized PCCP and, where practicable, a tracked changes version compared to the authorized PCCP.

For PMA devices, modifications implemented under a PCCP should be reported in the Annual Report, including updated labeling if applicable.

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Our recommendations

Here are the contours of our emerging roadmap for operationalizing a PCCP program into your program based on this guidance.

• Develop a PCCP strategy. Remember that PCCPs are most beneficial for devices that undergo frequent, predictable modifications. An example might be a a glucose monitoring system that regularly updates its software algorithm. Evaluate your device portfolio to identify products that could benefit from a PCCP. Consider planned modifications and assess whether they align with the types of changes appropriate for PCCPs. Pay particular attention to the specific examples provided in the guidance for your device type.

  • Consider creating a matrix mapping device types to potential PCCP-eligible modifications.

  • Prioritize high-volume or critical devices where reducing the submission burden would have the most impact.