R0021/2026-03-25/Q004/SRC02¶
FDA AI/ML SaMD Guidance
Source¶
| Field | Value |
|---|---|
| Title | FDA AI/ML SaMD Guidance |
| Publisher | FDA |
| Author(s) | FDA |
| Date | 2024 |
| URL | https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device |
| Type | Government regulatory guidance |
Summary¶
| Dimension | Rating |
|---|---|
| Reliability | High |
| Relevance | High |
| 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 | Official government regulatory guidance. |
| Relevance | Directly addresses AI validation in a regulated industry. |
| Bias flags | Regulatory bodies may be conservative in acknowledging gaps. |
Evidence Extracts¶
| Evidence ID | Summary |
|---|---|
| SRC02-E01 | GMLP 10 principles; predetermined change control plans; 97% via 510(k) |