Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review
Comparing public clearance records with marketing material highlights the importance of consistent product claims.
What the paper explores
This systematic review compared public 510(k) summaries with marketing materials for AI and machine-learning-enabled medical devices. The authors identified products whose public descriptions did not align clearly with their clearance documentation, illustrating the need to distinguish authorized intended use from promotional language.
How to interpret the evidence
The review covers a historical sample and publicly available documents. It is not a statement of current FDA policy, and absent details in a summary do not prove that FDA never reviewed them.
Questions for MedTech teams
Maintain traceability between the intended use, evidence, submission, labeling and website claims. Marketing review should be connected to regulatory document control.
Sources & further reading
Read original paperDOI: 10.1001/jamanetworkopen.2023.21792
Bibliographic record and abstract on PubMedThis is a short editorial reading note on external research. The original research is attributed to its authors and does not represent an HMC study, product validation or regulatory determination.
