FDA-recognized standard · General I (QS/RM)
ISO 20417: Medical devices - Information to be supplied by the manufacturer
Yes. FDA recognizes ISO 20417 Second edition 2026-03 as recognition 5-149, entered 2026-05-25. FDA also lists ISO 20417 First edition 2021-04 Corrected version 2021-12 (recognition 5-135, transition period ending 2029-07-01).
Recognized editions of ISO 20417
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-149 | ISO 20417 Second edition 2026-03 | 2026-05-25 | Complete | — |
| 5-135 | ISO 20417 First edition 2021-04 Corrected version 2021-12 | 2022-12-19 | Complete | 2029-07-01 |
Product codes that cite ISO 20417
No product code cites ISO 20417: 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.