FDA-recognized standard · Ophthalmic
ISO 11978: Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)]
Yes. FDA recognizes ISO 11978 Third edition 2017-08 [Including AMD1:2020] as recognition 10-141, entered 2025-12-22.
Recognized editions of ISO 11978
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 10-141 | ISO 11978 Third edition 2017-08 [Including AMD1:2020] | 2025-12-22 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 11978: 21 CFR 886.5916, 21 CFR 886.5918, 21 CFR 886.5925, 21 CFR 886.5928.
Product codes that cite ISO 11978
16 FDA product codes cite ISO 11978, including HQD, HRC, HRD, LPL, LPM.
- HQD Lens, Contact (Other Material) - Daily
- HRC
- HRD
- LPL Lenses, Soft Contact, Daily Wear
- LPM
- LPN Accessories, Soft Lens Products
- LRX
- LYL
- MRC
- MUW
- MVN
- MWL
- MZD
- NCZ
- NIC
- NUU
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.