The use of predetermined change control plans to enable the release of new versions of software as a medical device.

Abstract

Objectives: This study investigates how Predetermined Change Control Plans (PCCPs) can support the Software Development Life Cycle (SDLC) of certain Software as a Medical Device (SaMDs).

Methods: Targeted surveys collected qualitative and quantitative data on the current regulatory change process for SaMD; the use of PCCPs; the potential parameters of PCCPs in terms of technical, clinical, usability and administrative changes to SaMD; and whether PCCPs could be used more broadly for all SaMD.

Results: Results indicate that the current regulatory approach is not fit for purpose, specifically regarding fast-moving SaMD or continuous-learning AI SaMD. There was strong support for PCCPs to cover device technology, usability, and administrative changes, while clinical changes had limited support and required further investigation. The EU lags behind the US and now the UK in addressing these challenges and should look to legislate and implement PCCPs to ensure ongoing innovation and investment in digital health technologies.

Conclusion: This work is novel in the gathering of meaningful input from experts, practitioners, and regulatory professionals within the SaMD industry located in the EU, UK and US on the value and need for PCCPs. This study has implications for practice and policy as it can inform SaMD guidance and legislation.