Originally Posted by
eyewars
I have been told that our lens supplier is not using an appropriate acceptable standard.
Obviously you purchased from a supplier that is not registered with the FDA. That makes it short and sweet for the FDA to block it at customs. You will have to have the whole shipment tested one by one and even then it is not guaranteed that it will be released.
Best solution is to send it back by Fedex and get a refund from whoever you bought it and paid in advance, because FDA registration will take a while for an approval and you will be stuck with Fedex storing charges.
Check drop ball test rules: http://www.allaboutvision.com/safety/safety-glasses.htm
Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers
Sunglasses
10. Q. Does impact testing apply to finished non-prescription sunglass lenses, i.e., sunglass lenses that need only to be inserted into a frame?
A. Yes. Under 21 CFR 801.410(c)(3), you must test a statistically significant sample of sunglass lenses from each production batch. The sample must be representative of the finished forms, including forms that are of minimal lens thickness and have been subjected to any treatment used to impart impact resistance. You must test all lenses in uncut-finished or finished form.
21 CFR 801.410(c)(3). If you choose to test the finished form, you should perform testing on a sample after the lens has been edged (cut to the shape of the frame) but before being put into the frame.
11. Q. Are clip-on sunglass lenses subject to impact testing?
A. Yes (21 CFR 801.410 (c)(3)). However, FDA intends to exercise its enforcement discretion regarding impact testing based on the following factors:- Whether the clip-ons are the same size or smaller than the prescription lenses upon which they are intended to be worn.
From: http://www.fda.gov/medicaldevices/de...cm070579.htm#8
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