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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 10-93
ANSI  Z80.27-2014 (R2019)
American National Standard for Ophthalmics - Implantable Glaucoma Devices
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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 7.4 Ethylene oxide sterilant residues
Rationale for Recognition
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).
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Intraocular Pressure Lowering Implant Class 3 OGO
§886.3920 Implant, Eye Valve Class 2 KYF
Relevant FDA Guidance and/or Supportive Publications*
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Claudine Krawczyk
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.