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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 057 Date of Entry 12/20/2021 
FR Recognition Number 10-127
Standard
ANSI  Z80.21-2020
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 that use recognition of optotypes and that are designed for general use including optotypes printed on opaque media, those intended for transillumination, electronically generated or projected displays. It does not apply to special testing of visual acuity, e.g., low-vision, or reverse polarity (e.g., white optotype on a dark background).
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
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 Contacts
 Bruce Drum
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6466
  Bruce.Drum@fda.hhs.gov
 Shulei Zhao
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  240-402-5358
  Shulei.Zhao@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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