IMDRF Posts Guidance for Predetermined Change Control Plans

The International Medical Device Regulators Forum (IMDRF) has posted a guidance for predetermined change control plans (PCCPs), a vital document for regulatory harmonization. The scope of this IMDRF document is limited to software, however, seemingly leaving non-software PCCP considerations without explicit guidance in most nations outside the U.S.

The final IMDRF guidance addresses the use of PCCPs for software generally and is not specific to artificial intelligence (AI) software. The guidance acknowledges that the PCCP concept can be applied to non-software medical technologies, although IMDRF did not state whether it has any plans to develop non-software guidance. At present, the group has no open or closed consultations for non-software PCCP guidance development.

The FDA has addressed the PCCP concept in two separate guidances, one of which is still in draft form. The scope of the Aug. 22, 2024, draft guidance for non-artificial intelligence (AI) device products includes PMA, de novo and 510(k) devices, but applies as well to the device component of a device-led combination product. This draft specifically mentions other FDA software-related guidances, such as the guidance for determining when changes to 510(k) device software should prompt a new regulatory filing.

The August 2025 FDA final guidance for PCCPs for AI is focused on AI software generally, but emphasizes machine-learning (ML) AI software in particular. This approach might be due to the ability of ML software to autonomously modify its own functionality, a feature not seen in non-AI software and non-software devices and diagnostics.

One of the common elements in existing PCCP guidances is a restriction on the impact of predetermined changes on the device’s intended use and/or the indication for use statements. The IMDRF guidance states that a software PCCP assumes the developer will retain the original intended use over the course of any planned changes.

The FDA's non-AI draft guidance states that a PCCP should not generally modify the intended use or the indication for use. However, there are possible exceptions regarding a class II (de novo and 510(k) devices) product’s indication for use. One of these is that the manufacturer can use a PCCP to subsequently amend the label for use with an additional device or device component, or an additional or new genetic variant, the latter presumably a nod to a PCCP for in vitro diagnostics.

For class III (PMA) devices, the developer may use a PCCP to specify a patient sub-population in the indication for use statement, assuming this sub-population is part of a larger patient population already identified in the indication for use statement. The FDA's PCCP guidance for AI largely mirrors the non-AI guidance regarding changes to the device's intended use and indications for use.

Australia’s Therapeutic Goods Administration (TGA) has also issued a draft guidance for PCCPs with a specific focus on software. TGA indicated that it seeks to stay closely aligned with the IMDRF guidance, but confirmed that it is not currently considering a PCCP framework for non-software devices. TGA noted that a change to the software's intended use statement would not be eligible for inclusion in a PCCP, adding that developers cannot use a PCCP program to institute vaguely described improvements in the functionality of the software.

IMDRF emphasized that PCCPs should be used with a focus on both device risk and evidence generated in the post-market setting to ensure the continued proper functionality of the software device. Another key consideration is that of software version control, which allows regulators to ascertain which version of the software was authorized. IMDRF also observed that PCCP premarket applications are typically more complex premarket filings than non-PCCP applications, which suggests a more complicated process for both the manufacturer and the regulatory agency.