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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
Standard
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.
Transition Period
FDA recognition of ANSI Z80.21-2010 (R2015) [Rec# 10-73] will be superseded by recognition of ANSI Z80.21-2020 [Rec# 10-127]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-73] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 10-73] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.1150 Chart, Visual Acuity Class 1 HOX
Relevant FDA Guidance and/or Supportive Publications*
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
 Bruce Drum
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  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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