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Nonprescription Sunglasses - Requirements for Class I Over-The-Counter Devices

This guidance applies to Class I nonprescription sunglasses, including clips (clip-ons), marketed as over-the-counter (OTC) devices worn for casual/fashion dress and general recreational activities. It excludes industrial eyewear, prescription eyewear, ready-to-wear reading glasses, and sport protective eyewear.

  1. Ensure compliance with impact resistance requirements through testing
  2. Verify materials meet biocompatibility and flammability requirements
  3. Validate optical properties claims through testing to relevant standards
  4. Review and update all labeling to meet requirements
  5. Maintain documentation supporting any marketing claims
  6. Assess if any intended uses or modifications require 510(k) submission
  7. Implement quality system controls for manufacturing and labeling
  8. Ensure proper registration and listing with FDA
  9. Review traffic signal recognition requirements if intended for driving use
  10. Train staff on limitations of exemption from 510(k) requirements

Key Considerations

Non-clinical testing

  • Must comply with impact resistance requirements per 21 CFR 801.410
  • Should be manufactured from nonflammable materials per Federal Hazardous Substances Act
  • Should meet optical properties as stated in labeling (UV blocking, polarizing, tinting, etc.)

Labelling

  • Must include name and place of business
  • Must include adequate directions for use
  • Must avoid false and misleading statements
  • Must have prominent labeling statements
  • Must include principal display panel
  • Must include statement of identity
  • Must include declaration of net quantity
  • Should include warnings about not being shatterproof
  • Should include guidance on selection and use criteria

Biocompatibility

  • Should be manufactured from materials that are non-toxic, non-irritating, and not capable of producing significant allergic reactions under normal use

Safety

  • Must meet impact resistance requirements
  • Should be nonflammable
  • Should meet traffic signal recognition requirements if intended for driving

Other considerations

  • ANSI Z80.3-1996: Nonprescription Sunglasses and Fashion Eyewear - Requirements
  • ISO 14889: Ophthalmic Optics - Fundamental Requirements for Uncut Spectacle Lenses
  • ISO 8980-3: Ophthalmic Optics - Uncut Finished Spectacle Lenses - Part 3, Transmittance Specifications and Test Methods
  • ISO 10993: Biological Evaluation of Medical Devices - Parts 1-12

Original guidance

  • Nonprescription Sunglasses - Requirements for Class I Over-The-Counter Devices
  • HTML / PDF
  • Issue date: 1998-10-08
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 2002abe9bc0d8bc476204411da231824
This post is licensed under CC BY 4.0 by the author.