Marisol International Transportation & Logistics Blog

FDA Import Alert: Eyewear Products

Posted by Chelsea Mitchell on May 21, 2015 9:07:00 AM

Summer is approaching, the days are getting warmer and the number of imported sunglasses is increasing. Upon importation, sunglasses are considered a medical device, which requires additional paperwork to be submitted to Customs and Border Protection (CBP) and the U.S. Food and Drug Administration (FDA) to obtain customs clearance. FDA also recently issued a new import alert for sunglass and eyeglass products originating from specific foreign manufacturers, affecting a number of eyewear importers.

importing eyewear what you need to know.jpg

During April, FDA issued an import alert stating that eyewear originating from a particular list of manufacturers, could legally be detained without physical sampling or analysis. After a series of exams, FDA identified that certificates from certain foreign manufacturers may not be valid. Therefore, these manufacturers have been added to the Red List and any product originating from these manufacturers could be detained upon arrival in the U.S. Also within the alert, FDA stated that surveillance of all impact-resistant lenses in eyeglasses and sunglasses from all countries is warranted. You can view the Red List in the FDA Import Alert here

Due to the harm which sunglasses could cause if the lenses are shattered, importers are required to submit specific test results to FDA. Under 21 CFR 801.410(c)(3), eyewear importers must supply a drop ball test certificate upon customs entry, stating that a statistically significant sample of lenses from each production batch were tested for resistance to breakage.

The terms referee test, "drop ball" test, and impact test are synonymous in the import world.  

A lens is fractured and not considered impact resistant if:

  1. it cracks through its entire thickness, including a laminar layer, if any, and across a complete diameter into two or more separate pieces; or 
  2. any lens material visible to the naked eye becomes detached from the ocular surface (i.e., the surface of the lens that is closest to the eye when the lens is in actual use). 

Results of the testing, a description of the test method, and the test apparatus should be maintained for at least 3 years. 

Additionally, 

  • U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA
  • foreign manufacturers must register their establishment with FDA and 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.

Marisol International works closely with FDA to ensure clients maintain import compliance. Prior to importing, account managers collaborate with customers to ensure proper documentation is in place. Additionally, Marisol's Licensed Customs Brokers (LCBs) will process the customs entry, and if flagged for exam, will coordinate the exam to expedite the import process. Contact us today to learn more about importing into the United States. 

Importer Checklist: Save Time and Money 

 

Topics: Importing, Compliance, Eyewear

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