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.
Recommended Actions
- Ensure compliance with impact resistance requirements through testing
- Verify materials meet biocompatibility and flammability requirements
- Validate optical properties claims through testing to relevant standards
- Review and update all labeling to meet requirements
- Maintain documentation supporting any marketing claims
- Assess if any intended uses or modifications require 510(k) submission
- Implement quality system controls for manufacturing and labeling
- Ensure proper registration and listing with FDA
- Review traffic signal recognition requirements if intended for driving use
- 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
- Exempt from premarket notification [510(k)] requirements unless making new therapeutic claims or using different fundamental technology
- Subject to general controls provisions of the Act
- Must maintain records supporting any marketing claims
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms
- 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
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