Recognized standard
CR34971:2022
FDA recognition 13-124 · AAMI · Software/Informatics
Key facts
| Recognition number | 13-124 |
|---|---|
| Designation | CR34971:2022 |
| Title | Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Software/Informatics |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: