FDA-recognized standard · General I (QS/RM)
ISO 14971: Medical devices - Application of risk management to medical devices
Yes. FDA recognizes ISO 14971 Third Edition 2019-12 as recognition 5-125, entered 2019-12-23.
Recognized editions of ISO 14971
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-125 | ISO 14971 Third Edition 2019-12 also ANSI AAMI ISO 14971: 2019 | 2019-12-23 | Complete | — |
Product codes that cite ISO 14971
No product code cites ISO 14971: it is a horizontal standard, applied across device types rather than tied to particular codes.
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.