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

Abstract

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