Incoming Shipment of Sunglasses Delayed at Customs in Kentucky

[kashacin]

Hey, folks.

I operate an ecommerce site for women's fashion sunglasses. I recently placed an order from China for new inventory - the package is being held at customs for FDA approval, as fashion sunglasses are considered medical devices and fall under the FDA's authority...

FDA is requesting medical device number with drop ball test from my manufacturer...

I've requested that my supplier get the certificate from their manufacturer but as I understand, a drop ball test is supposed to be run on every new batch of sunglasses produced? Do I understand that correctly? If that's the case, its not likely my supplier will send me a test that's been performed within the last 6 months even... ? I don't know...

Can someone shed some light on this? What is the FDA agent looking for exactly?

[RT]

Here are some references:
https://www.accessdata.fda.gov/scrip...cfm?fr=801.410

https://www.fda.gov/RegulatoryInform.../ucm070579.htm

Yes, all non-prescription sunglasses must be impact resistant. Your manufacturer must have statistically valid testing and each import must have documentation.

[kashacin]

Thank you! That was helpful.

After my initial post, I did some more research and I have a much better idea of what the FDA needs now.

Yes - I'll be waiting on the drop ball certificate from my supplier's manufacturer. I just wish there was a way to speed up this process. As of this moment, I need to consider this shipment lost and plan to import more inventory with the proper documentation. There's no telling how long this shipment will be held up even after I submit the drop ball certificate for the current shipment thats being held.

[Lab Insight]

Thank you! That was helpful.

After my initial post, I did some more research and I have a much better idea of what the FDA needs now.

Yes - I'll be waiting on the drop ball certificate from my supplier's manufacturer. I just wish there was a way to speed up this process. As of this moment, I need to consider this shipment lost and plan to import more inventory with the proper documentation. There's no telling how long this shipment will be held up even after I submit the drop ball certificate for the current shipment thats being held.

What a crock the FDA is. Nothing more than a make work project. All sunglasses from China are assembled with polycarbonate lenses that will pass any drop test - the FDA knows that.

[kashacin]

^ Thanks for your reply.

Hm - in another thread, someone made the comment that the FDA does these sweeps periodically just to justify their existence... maybe there's some truth to that...

[Don Gilman]

^ Thanks for your reply.

Hm - in another thread, someone made the comment that the FDA does these sweeps periodically just to justify their existence... maybe there's some truth to that...

I have imported both semi and finised lenses from India and china for the past 20+ years and have ALWAYS had to have a drop ball certificate. They did not just pick on you.

[kashacin]

^ Yes - I understand that many packages are chosen for review. However, this has never happened w/ inbound packages through USPS. This is my first time receiving shipments in the spring w/ UPS and DHL.