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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 051 Date of Entry 01/14/2019 
FR Recognition Number 10-114
Standard
ANSI Z80.28-2017
American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
Scope/Abstract
This standard specifies standardized methods for reporting the optical aberrations of eyes.
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.
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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