Recognized standard
TR 22979 Second Edition 2017-05
FDA recognition 10-120 · ISO · Ophthalmic
Key facts
| Recognition number | 10-120 |
|---|---|
| Designation | TR 22979 Second Edition 2017-05 |
| Title | Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3 |
| Scope (excerpt) | ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[19] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with… |
At a glance
- None 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: