Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun's ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

• Register with the FDA;
• Foreign Manufacturers Must Name a U.S. 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.

Registration & Device Listing with the FDA

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of sunglasses intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (21 CFR 807). Registration and listing provide FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

The schedule of annual registration user fees for fiscal year 2019 is:

The device listing requires the Class of the product and the product code. The following regulation numbers and product codes are for sunglasses:

• Class I, II, III: What Class is your medical device?

The FDA categorizes medical devices into three different classes, pursuant to 21 CFR Parts 862-892. FDA determines the level of regulatory control for each class.

• Class I items are subjected to the lowest level of scrutiny because they present a low level of risk.
• Class II devices require a Premarket Notification (510(k)) because they exhibit a moderate level of risk.
  • “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.”
  • 21 C.F.R. §807 states the requirements that meet a 510(k) submission. After properly submitting the 510(k), you should receive an FDA letter informing you that the device is substantially equivalent to a legally marketed device. Then you may commercially distribute the device in the United States.

Class III devices are used to support or sustain life and are held to the most stringent level of regulatory controls: requiring a premarket approval (PMA).

• Product Code
  • The Product Code is assigned to the medical device according to the classification of the device. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. the product code assists CBP officers, FDA officials, importers, and etc. in accurately identifying the class in which the medical device falls under and in tracking the medical device. For sunglasses (Non-Prescription Including Photosensitive), the Product Code is HQY. Below is the product classification as provided in FDA’s medical device database:

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. FDA’s has a helpful guidance document entitled, Quality System.

The Impact or Drop Ball Test

Upon importation, The FDA will work with U.S. Customs and Border Protection (CBP) by reviewing the entry to confirm the proper documentation was transmitted to CBP. A critical document FDA expects to be included with your entry packet is the “Drop Ball Test” certificate. A certificate illustrating the lens' compliance with the 21 CFR 801.410 should accompany each lot of 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.

FDA requires, pursuant to 21 CFR 801.410, that your sunglasses products pass the impact or drop ball test.  This test consists of a non-restricted steel ball being dropped on your sunglasses to test whether the sunglass fractures. The point of the test is to determine the level of performance of the sunglass.

A failure to include the “Drop Ball” certificate with your entry can result in a delay in your shipment by the FDA. To avoid any delays, make sure the Drop Ball Test results are attached to your shipping documents.

Import Alert 86-07: FDA Enforcement Actions for “Drop Ball” Certificate that Failed to Meet US Standards

Most recently, FDA issued Import Alert 86-07 in 2018 allowing for the detention without physical examination of sunglasses and eyeglasses manufactured by certain establishment listed on the Red List of Import Alert 86-07. The FDA Division of Imports (DIO) instructed FDA district offices to detain without physical inspection products from the manufacturers identified in the Red List for this import alert as their impact-resistant lenses in eyeglasses and sunglasses were analyzed by the FDA and were found to not be in accordance with 21 CFR 801.410. Note that while most import alerts are country-specific, Import Alert 86-07 is world-wide; meaning importers sourcing from any country must confirm their manufacturer impact testing meet FDA standards.

Unique Device Identification

Lastly, FDA requires a unique device identification (UDI). This is “designed to adequately identify devices through distribution and use.” 78 FR 58786. As a result of the UDI Rule (78 FR 58785), each device, label, and package requires its own Unique Device Identification (unless an exclusion has been granted). UDI’s are comprised of a combination of numeric and alphabetic variables, representing a (1) device identifier and (2) production identifier:

1. A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device (see 21 CFR 801.3), and
2. A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
   1. the lot or batch number within which a device was manufactured;
   2. the serial number of a specific device;
   3. the expiration date of a specific device;
   4. the date a specific device was manufactured; or/and
   5. the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

How to Obtain a UDI?

There are very specific technical requirements for UDIs. These requirements are set forth in 21 CFR §830.20. The technicality of the 21 CFR §830.20 led FDA to mandate that UDIs must be issued under a system operated by an FDA-accredited issuing agency and conform to certain international standards incorporated by reference in the UDI Rule under 21 CFR §830.10. It is critical that the FDA-accredited issuing agencies’ systems for issuing UDIs align with the UDI labeling requirements to ensure labelers to confidently use the FDA-accredited issuing agency’s system to develop UDIs that are in compliance with the UDI labeling requirements under 21 CFR §801.

How Can Diaz Trade Law Help You?

DTL assist large, medium, and small importers with FDA compliance and enforcement actions. If you are new to the importation of sunglass, we highly recommend a consultation with our firm as you want to ensure your goods are not detained upon importation and that your manufacturer stays off Import Alert 86-07. Diaz Trade Law provides expert advice on how to pre-comply with both CBP and FDA before you import your sunglasses.