An AI/ML-enabled device incorporates models that learn patterns from data to provide diagnostic, predictive, monitoring, or therapeutic functions. FDA maintains a public list of AI/ML-enabled devices that have been authorized. Most AI-enabled devices on FDA's list are in radiology, followed by cardiology and neurology, and most were cleared through 510(k). They are regulated as software functions, so they follow the same pathways, but FDA expects extra content on data management, model development, performance across subgroups and monitoring, as described in its draft guidance on AI-enabled device software functions issued in January 2025. In the EU, they must also meet the AI Act.

Why it matters

Most authorized AI devices today are 'locked' - the model weights do not change post-deployment. Adaptive systems require a Predetermined Change Control Plan (PCCP) to enable continued learning while maintaining oversight.

Common pitfalls

•Failing to establish a robust data management plan for training and validation data can lead to biased or ineffective AI/ML models.
•Assuming that an AI/ML model’s performance in a controlled development environment will perfectly translate to real-world clinical settings is a common misconception.
•Neglecting to implement a post-market surveillance strategy for AI/ML performance can result in undetected degradation or errors over time.
•Underestimating the cybersecurity risks associated with AI/ML models, including data poisoning or adversarial attacks, can compromise device safety and effectiveness.
•Not adequately documenting the AI/ML model’s design, development, and validation processes can lead to difficulties in demonstrating regulatory compliance.

Sources

FDA AI/ML-Enabled Device List · FDA
MDCG Software Guidance · MDCG
FDA - Software as a Medical Device (SaMD) · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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