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.
What You Need to Know? 👇
What are the FDA classification and regulatory requirements for nonprescription sunglasses?
Nonprescription sunglasses are classified as Class I medical devices under 21 CFR 886.5850. They’re exempt from 510(k) premarket notification since February 1998 but must comply with general controls, impact resistance requirements, and proper labeling regulations.
Do sunglasses need to meet specific impact resistance standards for FDA compliance?
Yes, all sunglasses must be fitted with impact-resistant lenses complying with 21 CFR 801.410. They should meet ANSI Z80.3-1996 impact resistance requirements but must be labeled as “not shatterproof” since they’re not unbreakable shields.
When would nonprescription sunglasses require 510(k) submission despite the exemption?
A 510(k) is required when sunglasses have different intended uses (like therapeutic claims for cataracts or color blindness treatment) or use fundamentally different technology than legally marketed devices, as these meet “reserved criteria” under section 510(l).
What labeling requirements apply to over-the-counter sunglasses under FDA regulations?
Sunglasses must comply with 21 CFR Part 801 labeling requirements including name/place of business, intended use, adequate directions, principal display panel, statement of identity, and impact resistance labeling stating lenses “ARE NOT SHATTERPROOF.”
What manufacturing standards should be considered for sunglasses biocompatibility and safety?
Manufacturers should assess impact resistance (ANSI Z80.3), flammability (Federal Hazardous Substances Act), biocompatibility (ISO 10993), and optical properties. Materials should be non-toxic, non-irritating, and non-allergenic under normal use conditions.
Can sunglasses make UV protection claims without additional FDA clearance?
Sunglasses meeting ISO 8980-3 or ANSI Z80.3 UV requirements can claim UV protection and may be labeled as blocking specific percentages of UVA/UVB. However, therapeutic claims like “prevents cataracts” require 510(k) clearance as different intended uses.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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