| Area |
Publication or last update date |
Source organization |
Text |
Applied to the DM sector |
Key words |
| US |
2025 |
FDA |
Draft Guidance : Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations |
|
AI, life cycle, marketing submission |
| US |
2024 |
FDA |
Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan |
x |
AI, medical device, software, action plan |
| US |
2024 |
FDA |
FDA, Santé Canada et MHRA : Nouveaux principes directeurs pour les DM contenant de l’IA |
x |
AI, guiding principles |
| US |
2024 |
FDA |
Methods and Tools for Effective Postmarket Monitoring of Artificial Intelligence (AI)-Enabled Medical Devices |
x |
AI, post-market monitoring |
| US |
2024 |
FDA |
Artificial Intelligence Program: Research on AI/ML-Based Medical Devices |
x |
AI, ML |
| US |
2024 |
FDA |
Addressing the Limitations of Medical Data in AI |
|
AI, limitation, data |
| US |
2024 |
FDA |
Evaluation Methods for Artificial Intelligence (AI)-Enabled Medical Devices: Performance Assessment and Uncertainty Quantification |
x |
AI, ML, performance, assessment, uncertainty |
| US |
2024 |
FDA |
Performance Evaluation Methods for Evolving Artificial Intelligence (AI)-Enabled Medical Devices |
x |
AI, performance, assessment |
| US |
2024 |
FDA |
Regulatory Evaluation of New Artificial Intelligence (AI) Uses for Improving and Automating Medical Practices |
x |
AI, regulation, evaluation |
| US |
2024 |
FDA |
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions – Draft Guidance |
x |
AI, marketing submission, PCCP |
| US |
2023 |
National Institute of Standards and Technology (NIST) |
The language of trustworthy AI: An in-depth glossary of terms |
|
AI, definition |
| US |
2023 |
Journal of the American Medical Informatics Association |
More than algorithms: an analysis of safety events involving ML-enabled medical devices reported to the FDA |
x |
AI, ML, safety, report |
| US |
2023 |
FDA |
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principle |
x |
PCCP, AI, medical device |
| US |
2022 |
Association for the Advancement of Medical Instrumentation (AAMI) |
CR34971:2022 Guidance on the Application of ISO 14971 to Artifical intelligence and Machine learning |
|
AI, ML |
| US |
2021 |
FDA |
Artificial Intelligence and Machine Learning in Software as a Medical Device |
x |
AI, ML, software, medical device |
| US |
2021 |
FDA |
Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan |
x |
AI, ML, software, medical device, action plan |
| US |
2021 |
FDA |
Good Machine Learning Practice for Medical Device Development: Guiding Principles |
x |
ML, medical device |
| US |
2020 |
American International Standrards Institute (ANSI)/ Consumer Technology Association (CTA) |
2089.1-2020 Definitions/Characteristics of Artificial Intelligence In Health Care |
|
AI, healthcare |
| US |
2019 |
FDA |
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback |
x |
AI, regulation, discussion |
| US |
2019 |
Xavier Health’s Artificial Intelligence Summi |
White Paper : Perspectives and Best Practices for Artificial Intelligence and Continuously Learning Systems in Healthcare |
x |
AI, best practice, healthcare |
