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Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the Food and Drug Administration (FDA). Although these devices are 510(k) exempt, several other FDA regulations apply:

• U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA;
• foreign manufacturers must register their establishment with FDA and name a United States Agent;
• manufacturers must list their devices with FDA;
• manufacturers must meet Quality System (QS) requirements set forth in 21 CFR 820,
• the lens for spectacles and/or sunglasses must be certified as impact resistant under 21 CFR Part 801.410.

Failure to comply with these requirements may result in detention of the device at the U.S. port of entry. These and other requirements are discussed in further detail below.

Registration

Instructions on how to complete establishment registration are available at Establishment Registration.

United States Agent

All foreign establishments must notify FDA of the name, address, and phone number of their United States agent. The United States agent must either reside in the U.S. or maintain a place of business in the U.S.

• United States agent

Device Listing

Manufacturers of magnifying spectacles, spectacle frames, prescription spectacle lenses and sunglases must list each of the devices manufactured by the firm. Medical Device Listing provides instructions on how to list your device.

The following regulation numbers and product codes are provided for your convenience.

Good Manufacturing Practices/Quality System Requirements

GMP/QS requirements are found 21 CFR 820, Quality System Regulation. The quality system regulation includes requirements related to methods used and the facilities and controls for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.

• Quality System

Impact Resistant Lens Requirements

Lenses for spectacles/sunglasses sold in the U.S. must comply with the impact-resistant lens regulation, 21 CFR 801.410, Use of impact-resistant lenses in eyeglasses and sunglasses. A certificate illustrating the lens' compliance with the 21 CFR 801.410 should accompany each lot of spectacle lenses/sunglasses seeking entry into the U.S. The certificate should reflect that the eyewear have been "sampled" and are impact resistant, using a statistically significant method.

Manufacturers may conduct drop ball tests, as described in 801.410(d)(2), or use an equal or superior test method. See photographs of Drop Ball Test Unit (impact tester)

Acceptable sampling methods include:

• ANSI/ASQC Z1.4/1993, Sampling Procedures and Tables for Inspection by Attributes
• ISO 2859-1/1999, Sampling Procedures for Inspection by Attributes -- Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection
• MIL-STD 105, meeting an Acceptable Quality Level of 6.5, General inspection level II.

See Impact-Resistant Lenses: Questions and Answers for additional guidance.

Labeling

Labeling regulations are provided in 21CFR 801.1 - 801.16.

• Labeling

Guidance for Industry

"Guidance Document for Nonprescription Sunglasses," will assist manufacturers, distributors, importers and other interested persons in understanding the regulatory requirements that are applicable to sunglasses.

Importing

Guidance on importing medical devices into the U.S. is available at Importing into the U.S.

If you need additional assistance, please call DSMICA at 240-276-3150 or e-mail DSMICA.

Division of Small Manufacturers, International and Consumer Assistance, HFZ-220
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health

Updated December 13, 2007

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