Sunglasses, Frames, Lens and Magnifying Spectacles
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices that are required to be listed with US FDA and the company must register with US FDA.
We at FDA Agents can take care of all these requirements for you, with our expert registration, device listing and US Agent service.
Among the FDA regulations that apply are:
* 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 device with FDA.
****the lens for spectacles and/or sunglasses must be certified as impact resistant.
If your products are sunglasses, frames, lens or spectacles, the required ESTABLISHMENT REGISTRATION and MEDICAL DEVICE LISTING can be completed here. To start the process and complete the registration and listing forms, just click "REGISTER MEDICAL" here or in the menu above.
We provide below for your information some common questions and answers about importing sunglasses and lenses, courtesy of the US FDA website. At the bottom you will find a Sample of the Certification Statement of Impact Resistance, required for import into the USA of sunglasses and lenses:
Importing Lenses, Eyeglasses, and Sunglasses
Q. What should be submitted to the FDA at the U.S. Port of Entry?
A. Nearly all commercial entries come to FDA through the U.S. Customs and Border Protection’s Automated Broker Interface (ABI) system submitted by a customs brokerage firm (or filer). FDA processes these entries electronically in its Operational and Administrative System for Import Support (OASIS) system. To streamline the entry process, we recommend that you use the affirmation of compliance code, IRC, for electronic entries or submit a "Certification Statement of Impact Resistance." We provide suggested wording for a certification statement [below].
If the lenses are manufactured outside the U.S., the foreign manufacturer should test the lenses prior to exporting to the U.S. The foreign manufacturer [or importer] should provide a certification of impact resistance with the shipment of finished lenses that requires no further processing, except for being inserted into a frame.
If you import semi-finished prescription or non-prescription lenses into the U.S., you should label the lenses, "Requires further processing, not a finished device.” Semi-finished lenses require further processing. Under these circumstances, the U.S. finished device manufacturer is responsible for performing the impact testing.
In addition to the certification statement, FDA reviews information you provide to demonstrate that the device meets FDA requirements. This includes registration number, device listing number, and U.S. Agent information for prescription spectacle lenses (21 CFR 886.5844), magnifying spectacles (21 CFR 886.5840), and sunglasses (nonprescription) (21 CFR 886.5850).
Q. What are FDA’s processes for inspection and/or sampling for testing of a shipment of lenses or sunglasses?
A. Ophthalmic devices are subject to inspection and/or sampling by the FDA as part of FDA's efforts to determine the device's compliance with the act. FDA does not inspect every import entry. FDA may request additional information or documentation, such as records of impact testing results, or request to examine the shipment. If FDA chooses to collect a sample, the District Office typically notifies the import broker (or filer), the owner or consignee, and importer of record (if different than owner or consignee) of its intent to sample.
Once FDA has been advised of the location and the availability of articles, the FDA personnel will visit the site to perform the examination and/or sample collection. FDA's examination of the entry and sample collection cannot proceed until the agency receives the "notification of availability." After collection of the sample, FDA typically provides an additional "Notice of FDA Action" detailing the articles and amounts collected. If the article is found to be in compliance after examination, the filer, importer of record, consignee, and the U.S. Customs and Border Protection (CBP) are notified by “Notice of Release” that the article may be admitted as far as FDA is concerned.
Q. If FDA tests the shipment at the port of entry, how many lenses are tested?
A. FDA will test a statistically significant sample size in order to determine compliance with the FDA impact test regulation. The sample size will depend on the size of the shipment that FDA is testing.
Q. What does the FDA testing lab do with sunglasses/eyeglasses after being tested?
A. Samples that are damaged are no longer suitable for use and are not returned to the importer. If requests are made to a District Office for the return of any non-damaged samples, FDA tries to comply with the requests.
Q. What should I do if my shipment is refused admission?
FDA may issue a “Notice of Detention and Hearing” to refuse admission of a shipment if the device appears to be in violation of section 801(a) of the act (21 U.S.C. 381(a)). FDA issues the "Notice of Detention and Hearing" detention to the broker (or filer), importer of record, and the owner or consignee, where applicable. The notice will specify the nature of the violation charged and will designate the place and period of time during which the owner or consignee (or authorized representative) can provide oral or written testimony as to the admissibility of the article.
Certification Statement of Impact Resistance
"__________________________________" (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)