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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 065 Date of Entry 12/22/2025 
FR Recognition Number 10-140
Standard
ANSI  Z80.1-2020
American National Standard for Ophthalmics - Prescription Ophthalmic Lenses - Recommendations
Scope/Abstract
This standard applies to all prescription dress ophthalmic spectacle lenses in edged or assembled form. It is a guideline for entities that fabricate, assemble or process dress eyewear or lens components. Relevant optical and physical specifications and tolerances of this standard also apply to uncut lenses.
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
886.5845 Prescription Spectacle Lenses To Reduce The Progression Of Myopia Class 2 QUR
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
 Jonathan Kim
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-7403
  Jonathan.Kim@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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