FDA-recognized standard · Biocompatibility
ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice
Yes. FDA recognizes ISO 14155 Third edition 2020-07 as recognition 2-282, entered 2020-12-21.
Recognized editions of ISO 14155
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-282 | ISO 14155 Third edition 2020-07 | 2020-12-21 | Complete | — |
Product codes that cite ISO 14155
No product code cites ISO 14155: 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.