| ANSI Z80.27-2014 American National Standard for Ophthalmics - Implantable Glaucoma Devices |
| Recognition Number | Ophthalmic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 10-93 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 7.4 Ethylene oxide sterilant residues |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Ophthalmic |
| FDA Tech | Claudine Krawczyk FDA/OMPT/CDRH/ODE/DOED/ICIB/ 301-796-6860 claudine.krawczyk@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Clause 7.4 (ethylene chlorohydrin limit) conflicts with an existing published final guidance. See guidance #2 below (MIGS). Clause 7. 4 (ethylene oxide limit) conflicts with another recognized standard. See reference #4 below (ISO 11979-8).
The scope of this standard applies to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect depends upon metabolic and/or pharmacologic mechanisms.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.3920 | Implant, Eye Valve | Class 2 | KYF |
| Unclassified | Intraocular Pressure Lowering Implant | Class 3 | OGO |
| 1. Guidance for Industry and for FDA Reviewers/Staff: Aqueous Shunts - 510(k) Submissions, Issued November 16, 1998. 2. Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration Staff, Issued December 15, 2015. 3. Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 17, 2015. 4. ISO 11979-8 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements. |