In the dynamic landscape of healthcare technology, medical devices are not static entities; rather, they are continually evolving to meet the demands of patient care, technological advancements, and regulatory requirements. However, modifying a medical device may require the manufacturer to engage with regulatory authorities again through a lengthy review process, possibly delaying the updated device’s release to patients and healthcare practitioners. While the EU is still struggling with other aspects of the MDR implementation, the FDA has been pushing forward its “Predetermined Change Control Plan” policy (PCCP), which provides manufacturers with a new regulatory tool for managing device changes efficiently.
History of the US FDA PCCP
In the US, the FDA has long acknowledged the regulatory burden associated with device modifications, particularly software-based products where changes are implemented much faster. As a possible response, the FDA introduced the concept of a “Predetermined Change Control Plan” (PCCP) in 2019 through a discussion paper[1] and was officially granted the authority to review and approve PCCPs in 2022. In 2023 and 2024, two PCCP-related draft guidance documents were published, the first focusing specifically on AI/ML-enabled devices[2] and the second applying to all product types[3].
According to search data published by B. O’Leary[4], it is estimated that more than 50 PCCPs had already been approved by March 2025 showing the industry’s interest in this new regulatory tool (see Figure 1).
Figure 1 : Approximative cumulative number of FDA submissions cleared/approved with a PCCP, as of 09.03.2025, based on data published by B. O’Leary5
PCCP purpose and scope
In a nutshell, the PCCP policy allows manufacturers to obtain the FDA’s anticipated clearance/approval for specific, pre-defined changes that would otherwise require a new submission before implementation. Changes that are eligible for inclusion in a PCCP must maintain or improve device safety and effectiveness, be verified and validated, and, as said before, typically require a new submission to the FDA.
With such a broad expression of inclusion criteria, one may think that almost any “significant” change can be included in a PCCP. There are, however, limitations, in particular for changes that may impact:
- the device’s intended use;
- the device indications for use (exceptions may be possible);
- the device’s substantial equivalence to its predicate (for 510k devices).
In addition to these generic exclusions, the 2024 FDA draft Guidance “Predetermined Change Control Plans for Medical Devices”4 provides more detailed information to determine if a particular modification is eligible for inclusion in a PCCP. It is worth noting that this FDA guidance proposes different decision flowcharts for PMA devices and 510k/DeNovo devices, with obviously more restrictions on eligible changes to high-risk devices.
How to get your PCCP approved
PCCPs may be approved by the FDA through the PMA, DeNovo or, 510k pathways. It requires manufacturers to provide the FDA with specific information through a dedicated section in an original submission or a supplement to an existing submission.
At a minimum, the following information should be included in PCCP submissions:
- description of the planned modifications
- modification protocols,and
- modification impact assessments
The description of planned modifications should be sufficiently detailed to allow FDA reviewers to understand the nature of each modification and include information on how device characteristics and performance are changed. It is important to stress that the FDA expects PCCPs to address a limited number of specific modifications and not all changes that a manufacturer may think of.
The modification protocol should include a thorough description of how each change will be developed, implemented, verified, validated and documented. A strong focus is placed here on the test methods and acceptance criteria that will be used to demonstrate that the device remains safe and effective after the change implementation. In addition, modification protocols should also address plans for communicating the changes to device users/patients and updating or conducting the related training as appropriate.
The impact assessment is intended to demonstrate that the individual proposed modifications and their combination are unlikely to introduce additional, unmitigated risks. It should also justify that the device's safety and effectiveness are maintained. It should provide an analysis of the benefits and risks related to the planned changes, along with a description of all risk mitigation measures. It also provides an analysis of how each modification implementation may impact the implementation of another and should describe the cumulative impact of all modifications.
Finally, the FDA expects manufacturers to maintain clear traceability between planned modifications and the related modification protocols. Manufacturers are also advised to be able to trace the impact/risk assessments performed on each modification.
Conclusion
The FDA's Predetermined Change Control Plan (PCCP) policy offers a structured approach for obtaining pre-approval for specific changes to medical devices, providing significant advantages to manufacturers. Understanding the nuances of PCCPs is crucial to QA/RA professionals, as a well-implemented PCCP can streamline the change management process, allowing for more efficient handling of certain device modifications while reducing the regulatory submission burden. PCCPs, however, do not come for free. The complexity of implementation can demand substantial resources, particularly for smaller organizations or manufacturers of complex, innovative devices. As the PCCP program is fairly new, both the FDA and the industry are still going through a steep learning curve. It is therefore strongly advised to engage early with the FDA through Pre-submission to obtain feedback on a proposed PCCP before including it in a pre-market submission.
[1] US FDA Artificial Intelligence and Machine Learning Discussion Paper
[2] Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
[3] Predetermined Change Control Plans for Medical Devices
[4] B. O’Leary, “List of FDA authorized devices with Predetermined Change Control Plans”
