By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. Javitt —
A recent draft guidance on predetermined change control plans (PCCP) for medical devices continues FDA’s effort to implement Section 515C of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which Congress enacted to make it easier for manufacturers to make post-market device changes by avoiding the need for additional FDA authorization (see our prior summary of FDORA here). A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here; this guidance has not yet been finalized. In contrast, the new draft guidance, Predetermined Change Control Plans for Medical Devices (Draft Guidance), addresses all device types, and describes the types of modifications that the agency “believes generally may be appropriate for inclusion in a PCCP, and the information that should be included in a PCCP in a marketing submission for any device type.” Draft Guidance at 4.
As a reminder, a PCCP is a document submitted in a marketing application that describes future modifications to a device that would typically require submission of a subsequent application and a description of how the sponsor will verify and validate the modified device.
FDORA gives wide latitude to FDA with respect to the types of changes that may be made to a device with an approved or cleared PCCP. The statute states that FDA may approve a PCCP for a PMA device for any change that would otherwise require a supplemental application as long as the device remains safe and effective without any change. For 510(k) devices, FDA may authorize a PCCP as long as the changes would not affect the device’s substantial equivalence to the predicate device and the change is not necessary to maintain the device’s safety and effectiveness without any change.
The Draft Guidance takes a narrower approach. For 510(k) devices, PCCPs can be considered for modifications that “significantly modify an existing risk”, but generally not for those that “introduce a new risk.” Id. at 20. Longstanding guidance on evaluating postmarket device changes, Deciding When to Submit a 510(k) for a Change to an Existing Device (Change Guidance), states that a change “could significantly affect the safety or effectiveness of the device”—and requires a new 510(k)—if it either introduces a new risk or significantly modifies an existing risk. Change Guidance at 8. Given that this prior FDA guidance treats both types of changes—modifications to existing risk and introduction of new risks—as significant and likely to require a 510(k) submission, logic dictates that, in determining PCCP eligibility, FDA should apply it to both categories of change since the purpose of a PCCP is to avoid the need for a new marketing submission. In fact, FDORA does not preclude PCCPs for changes that introduce a new risk, as long as the device remains safe and effective without any change and remains substantially equivalent to the predicate. Nevertheless, the Draft Guidance would preclude the use of PCCPs for such changes, even if the modified device would remain substantially equivalent to the predicate device. Likewise, for PMA devices, the Draft Guidance would preclude use of a PCCP for changes that are considered major or that modify the intended use of the device. As both these categories of changes are currently permitted via a PMA supplement, and the goal of FDORA is to provide an alternative to the need for such supplements, we would expect major changes and modifications to intended use to be permissible via a PCCP as long as the device remains safe and effective without any change.
The Draft Guidance includes examples of changes that would be eligible for PCCPs, as well as those that would continue to require new submissions. These examples further demonstrate that FDA is narrowing the scope of PCCP-eligible changes contemplated under FDORA. For instance, the Draft Guidance states that a PCCP would be appropriate to add a device to a product with different dimensions that are within the range of dimensions of those currently authorized. Under the Change Guidance, such change would likely be classified as non-significant, meaning that no additional submission would be necessary even without a PCCP, so it is unclear how this example furthers the goal of FDORA. On the other hand, the Draft Guidance states that a significant change to the design of a printed circuit board (PCB) in a multi-parameter physiological patient monitor, with arrhythmia detection alarms for use in a hospital environment, would not be appropriate for inclusion in a PCCP. Draft Guidance at 34. As described, this change would not appear likely to introduce a new risk, making it unclear why it could not be implemented via a PCCP.
The Draft Guidance also provides detail regarding the content of a PCCP, stating that the sponsor should include:
- a description of the modification, including specific changes to the device characteristics and performance;
- a modification protocol, including performance evaluation methods and update procedures;
- traceability between the description of the modifications section and the modification protocol section; and
- an impact assessment. Id. VII.
FDA recommends a PCCP include “only a limited number of modifications that are specific, and that can be verified and validated.” Id. at 26. Practically speaking, we agree that limiting the number of modifications in a PCCP will be most efficient for sponsors to achieve timely submission and authorization, but again, FDORA does not impose this limitation. If a sponsor is able to provide a detailed description of multiple changes with appropriate performance evaluation methods for each, we hope the Agency will be willing to consider them under a single PCCP.
Finally, the Draft Guidance indicates that a PCCP may be included with most application types. For PMA devices, a PCCP may be included with an original application, modular application, or any of the pre-approval supplement types (panel-track, real-time, 180-day, 135-day). A PCCP may also be submitted as part of a De Novo application. For 510(k) devices, a PCCP may be submitted only with a traditional or abbreviated application. We find it surprising that a PCCP may not be submitted with a Special 510(k), given a Special 510(k) may be used to modify an existing device where well-established methods are available to evaluate the change. FDA, Guidance for Industry, The Special 510(k) Program (2019). Given the limitations in the Draft Guidance for types of changes that may be made using a PCCP, it seems that changes eligible to be made via a Special 510(k) may be well suited for being made via a PCCP. The Draft Guidance states that Special 510(k)s may be an appropriate submission type if the Sponsor wishes to modify a previously cleared PCCP for their own device and the PCCP methods are well-established. Given FDA appears prepared to permit modification of an existing PCCP via a Special 510(k), it remains unclear why one could not implement a PCCP via the Special 510(k) pathway in the first instance.
While the description of the content that should be included in a PCCP is generally helpful, the Draft Guidance leaves much uncertainty—and uneasiness—about the types of changes FDA will ultimately allow manufacturers to make via the PCCP process.
Comments on the Draft Guidance may be submitted until November 20, 2024.
