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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 10-73
ANSI Z80.21-2010 (R2015) American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
Scope/Abstract
This standard applies to displays of optotypes for all clinical visual acuity measurement systems thatuse recognition of high-contrast optotypes and that are designed for general use including optotypesprinted on opaque media, those intended for transillumination, electronically generated or projected displays.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.1150 Chart, Visual Acuity Class 1 HOX
FDA Technical Contact
 Bruce Drum
  FDA/OMPT/CDRH/ODE/DOED/DSDB/
  301-796-6466
  bruce.drum@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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