| ACP | Algorithm Change Protocol | The detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented. |
| CDS | Clinical Decision Support | Software providing healthcare professionals with knowledge and patient-specific information. |
| GMLP | Good Machine Learning Practice | Guiding principles for the development of AI/ML-enabled medical devices. |
| MDDS | Medical Device Data System | Hardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act amendments. |
| MLOps | MLOps for Medical Devices | The set of practices and tooling for deploying, monitoring, retraining, and governing machine learning models in regulated medical device software environments. |
| PCCP | Predetermined Change Control Plan | FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. |
| SaMD | Software as a Medical Device | Software intended for medical purposes that performs without being part of a hardware device. |
| SiMD | Software in a Medical Device | Software embedded in or required to operate a hardware medical device. |
| SOUP | Software of Unknown Provenance | Software not developed for medical device use, or lacking adequate development records, incorporated into a device. |
| TIR45 | AAMI TIR45 | AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. |
| TPLC | Total Product Lifecycle | FDA framework integrating premarket and post-market oversight across a device's life. |