Guide to US Sunglasses and Eyewear Regulations

Sunglasses and eyewear sold in the United States are subject to various regulations and standards. In this guide, we cover requirements related to the following product areas:

• Nonprescription Sunglasses – 21 CFR
• Prescription Glasses – 21 CFR
• Workplace Eyewear – OSHA
• Children’s Eyewear – CPSIA
• Smart Glasses

Nonprescription Sunglasses – 21 CFR

The FDA regulates nonprescription sunglasses as medical devices, even though these products can generally be purchased over the counter, without a doctor’s prescription.

Classification

Nonprescription sunglasses are classified by the FDA as Class I (general controls) devices, as explained in 21 CFR Part 886.5850.

According to the FDA, these are products that consist of “spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses “ that are designed to protect human eyes from the sunlight, without providing refractive corrections.

The devices are exempt from premarket notification requirements.

Standards

I found the following standards listed on the FDA’s Guidance Document for Nonprescription Sunglasses:

Name	Products	Description
ANSI Z80.3 – Ophthalmics – Nonprescription Sunglass and Fashion Eyewear Requirements	Nonprescription Sunglasses, fashion Eyewear	This standard covers nonprescription sunglasses and fashion eyewear, which are generally used for casual, dress, or recreational purposes.
ISO 14889 – Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses	Spectacle lenses	This standard specifies requirements for uncut finished lenses. It does not apply to protective lenses.
ISO 8980-3 – Ophthalmic optics — Uncut finished spectacle lenses	Spectacle lenses	This standard sets requirements for the transmittance properties of finished spectacle lenses, such as attenuation of solar radiation.

Registration and listing

Manufacturers and other operators involved with the distribution of sunglasses and other medical devices must register with the FDA and list their devices electronically.

You can find the database under the “Establishment Registration & Device Listing” page on the FDA’s website.

Good manufacturing practice

Manufacturers must also follow current good manufacturing practice (CGMP) as listed in 21 CFR Part 820. In particular, the FDA incorporated by reference ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.

Certification statement

A certification statement of impact resistance is generally needed (Link):

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“__________________________________” (Name of manufacturer or seller) hereby guarantees that the articles listed herein are impact-resistant within the meaning of 21 CFR 801.410 and have been tested pursuant to that section. Impact-resistant lenses are not unbreakable or shatterproof. Records of testing will be maintained for a period of three (3) years from the date of shipment, and copies will be forwarded to FDA upon request.

(Signature and street address of manufacturer or seller)

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Labeling

Class I medical devices must comply with the labeling requirements set in 21 CFR Part 801 – Labeling. In particular, the FDA’s Guidance Document on sunglasses explains that these devices must comply with the following subparts:

a. Subpart A – General labeling provisions:

• Name and place of business
• Intended use
• False and misleading statements
• Prominence

b. Subpart C – Labeling requirements for over-the-counter devices:

• Principal display panel (statement of identity placement)
• Statement of identity (e.g., common name)
• Quantity

c. Subpart D – Exemptions from adequate directions for use – I understand sunglasses are exempt because they are deemed to be objects of common use.

d. Subpart H – Special requirements for specific devices – I understand this concerns the use of impact-resistant lenses, but I could not find specific labeling requirements.

Testing

You must test your sunglasses to ensure that they are safe for users. Here are some of the main properties that should be tested using appropriate standards and testing methods:

a. Impact resistance: Lenses should comply with the impact resistance requirements listed in 21 CFR Part 801.410.

b. Flammability: Sunglasses should be manufactured using materials that are deemed not flammable according to the Federal Hazardous Substances Act and 16 CFR Part 1500.44.

c. Biocompatibility: Sunglasses should be produced using materials that are non-toxic, non-irritating, and non-allergic (e.g., in accordance with ISO 10993 – Biological Evaluation of Medical Devices – Parts 1-12).

d. Optical properties: Sunglasses should be built using lenses that attenuate sunlight and have the characteristics stated in the label, advertising, etc. (e.g., UV blocking).

Prescription Glasses – 21 CFR

This section covers requirements for prescription spectacle frames and spectacle lenses. Such products are intended to provide refractive corrections in accordance with a prescription made by a doctor.

Classification

The FDA classifies prescription glasses as Class I devices (general controls), as explained in 21 CFR Part 886. In particular, I found the following classifications:

a. 886.5842 Spectacle frame – This is defined as a metal or plastic device intended to hold prescription spectacle lenses that correct refractive errors.

b. 886.5844 Prescription spectacle lens – These are defined as lenses that provide refractive corrections. They can also be modified to protect from bright sunlight or have other properties such as being reflective, tinted, polarizing, or photosensitized.

Both types of devices are exempt from premarket notification procedures as set in 21 CFR Part 807.

Standards

Name	Products	Description
ANSI Z80.1 – Ophthalmics – Prescription Ophthalmic Lenses – Recommendations	Prescription ophthalmic lenses	This standard provides guidelines for the fabrication, assembly, and processing of eyewear and lenses.
ISO 12870 – Ophthalmic optics – Spectacle frames – Requirements and test methods	Spectacle frames	This standard specifies requirements and test methods for spectacle frames manufactured to be used with prescription lenses.

Registration and listing

Even though spectacle frames and prescription spectacle lenses are exempt from premarket notification, you must still register your establishment and list your device on the FDA website.

If you are unsure how to proceed, you can also contact an agency that specializes in helping companies that manufacture, import, and distribute products covered by the FDA.

Good manufacturing practice (GMP)

Unless exempt, all medical devices must comply with the current good manufacturing practice (CGMP) provided in 21 CFR Part 820. This also includes spectacle frames and prescription spectacle lenses.

These requirements include:

a. Documentation

b. Compliance with appropriate standards, such as ISO 13485

c. Record maintenance.

Certification statement

As for nonprescription sunglasses, a certification statement of impact resistance is required.

Labeling

Spectacle frames and prescription spectacle lenses must comply with the labeling requirements set in 21 CFR Part 801 – Labeling:

a. Subpart A – General labeling provisions

b. Subpart B – Labeling Requirements for unique device identification

c. Subpart H – Special requirements for specific devices (e.g., impact resistance lenses)

Note that I did not list subparts that concern over-the-counter devices, subparts that contain exemptions (as I could not find specific exemptions for spectacle frames and prescription spectacle lenses), and subparts that are reserved.

You can visit the page Unique Device Identification System (UDI System) on the FDA’s website to learn more about the UDI system, which allows for unique identification of devices.

Testing

According to 21 CFR 801.410, eyeglasses must be fitted with impact-resistant lenses. The only exception that I found is in the case in which a doctor deems that such lenses disturb the patient’s vision (and declares it in writing).

In particular, each impact-resistant glass lens for prescription use should be individually tested and capable of withstanding the impact test laid out in paragraph (d)(2) of 21 CFR 801.410.

Besides that, other tests may also be necessary, such as those that cover flammability, biocompatibility, and optical properties.

Workplace Eyewear – OSHA

In general, the Occupational Safety and Health Act (OSH Act) requires employers to provide a safe environment for their workers. According to the job, this will also include the provision of compliant safety equipment such as spectacles, goggles, and other eye protection devices.

Here are some examples of employees who often need to wear eye protection equipment:

• Welders
• Laser operators
• Chemical workers

Requirements

These are the requirements that I could find under 29 CFR Part 1910.133 – Eye and Face Protection:

a. Employers should ensure that their employees use adequate protective devices when exposed to danger

b. The devices should be marked in order to ensure the identification of the manufacturer

c. Filter lenses should have an appropriate shade number, according to the task

d. Protective eye devices should comply with the ANSI Z87.1 standard, which is incorporated by reference under 29 CFR Part 1910.133

Standards

Name	Products	Description
Z87.1 – American National Standard for Occupational and Educational Personal Eye and Face Protection Devices	Eye protection devices, Face protection devices	This standard sets testing, marking, care, and other requirements of eye and face protection devices.
ANSI Z136.7 – Testing and Labeling of Laser Protective Equipment	Eye protection equipment	This standard sets recommendations for the testing and labeling of equipment that protects the user from lasers, including eye protection equipment.

Children’s Eyewear – CPSIA

Sunglasses and other eyewear intended for children aged 0 to 12 years of age must comply with requirements under the CPSIA. The key requirements are explained below:

1. Children’s eyewear must comply with all applicable children’s product safety rules

2. Lead and phthalates are restricted in materials

3. Third-party testing is mandatory

4. A Children’s Product Certificate (CPC) must be issued

5. Tracking labels must be affixed to the product and the packaging

As of 2026, eFiling is also required for children’s products imported to the United States.

Smart Glasses

Smart Glasses are a relatively new class of products that are subject to several regulations for electronic products. The table below lists several US regulations and standards which may be relevant for smart glasses.

Title	Scope	Relevancy
FCC intentional radiators	Electronic devices	Smart glasses have Bluetooth and WiFi to communicate with other devices.
47 CFR Part 8 Subpart B – Cybersecurity Labeling Program for IoT Products	Electronics connected to the Internet	Smart glasses can connect to the Internet.
16 CFR Part 1263 – Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries	Button cell or coin batteries and products containing them	Smart glasses may be equipped with button cell or coin batteries. This standard sets safety, labeling, and other requirements.
49 CFR Subtitle B Chapter I Subchapter C – Hazardous Materials Regulations	Batteries	Smart glasses may contain lithium batteries or other covered batteries.
UL 4200A – Standard for Safety for Products Incorporating Button Batteries or Coin Cell Batteries	Products containing button cell or coin batteries	This standard is incorporated by reference under 16 CFR Part 1263.
UL 1642 – Lithium Batteries	Lithium	Smart glasses may contain lithium batteries. Thus, it is important to ensure such batteries are safe.

Other Requirements

The following compliance requirements are not specific to eyewear but are still of high importance.

Country of Origin

Country of origin is mandatory for almost any product sold in the US, which includes sunglasses and other types of eyewear.

The stated country of origin must reflect the manufacturing country. For example, sunglasses manufactured in Wenzhou must be marked as Made in China.

Note that strict rules apply to products that are marked as Made in the USA.

Examples

• Made in the USA
• Made in China
• Made in Italy
• Made in Germany

Lense origin

Some brands use lenses made in one country, while the final eyewear product is assembled in another. For example, it is not uncommon that brands manufacture eyewear in China, using Made in Italy lenses from Zeiss and other brands.

A ruling from 1994 stated that such products are still to be considered as made in the country where the final product was made, but with the option to also specify the lens origin.

California Proposition 65

California Proposition 65 sets substance restrictions for consumer products sold in California, which includes sunglasses and other types of eyewear.

Plastic frames and coatings can contain DEHP and other restricted substances above the set limits.

Companies essentially have two options:

1. Arrange third-party testing to verify if the substance content is below the set limits

2. Affix CA Prop 65 warning labels