R0043/2026-04-01/Q002/SRC04
FDA AI-Enabled Device Software Functions guidance
Source
| Field |
Value |
| Title |
Artificial Intelligence-Enabled Device Software Functions |
| Publisher |
U.S. Food and Drug Administration |
| Author(s) |
FDA |
| Date |
January 7, 2025 (draft guidance) |
| URL |
https://www.fda.gov/media/184856/download |
| Type |
Regulatory guidance (draft) |
Summary
| Dimension |
Rating |
| Reliability |
High |
| Relevance |
Medium |
| Bias: Missing data |
Low risk |
| Bias: Measurement |
N/A |
| Bias: Selective reporting |
Low risk |
| Bias: Randomization |
N/A -- not an RCT |
| Bias: Protocol deviation |
N/A -- not an RCT |
| Bias: COI/Funding |
Low risk |
Rationale
| Dimension |
Rationale |
| Reliability |
FDA is the authoritative regulator for medical devices in the US |
| Relevance |
Addresses human factors and accuracy in AI medical devices but does not name sycophancy |
| Bias flags |
Government agency; no commercial interest |
| Evidence ID |
Summary |
| SRC04-E01 |
FDA requires human factors evaluation and accuracy metrics for AI devices but does not address sycophancy-specific risks |