Recognized standard
11980 Fourth edition 2025-06
FDA recognition 10-139 · ISO · Ophthalmic
Key facts
| Recognition number | 10-139 |
|---|---|
| Designation | 11980 Fourth edition 2025-06 |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing… |
At a glance
- 10–99 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: