Hope you can help me.
I sent hand sample of sunglasses to USA by fedex and unfortunately the partial was held. Fedex said custom department requested me to provide FDA number , 510k number and drop ball test certificate. How come ?? this is a hand-made sample , how can I provide drop ball test certificate??
Also, for FDA reg and 510k number, is this necessary for all suppliers if supplier want to send sample to USA??
Request those infor from your lens suppliers.
Connie Poon from Elegence Optical is quite familiar with the process. Contact her to assist you.
Jerry, the point is the sample is hand-made samples.......Originally Posted by JERRY HUANG
I have never met this situation before. It make me crazy. :angry: How can hand-made sample pass the drop ball test. It's doesnt make sense...If the sample have no commercial value, I still need to submit the document???
No promises of accuracy nevertheless the following may help.
The fact that it is a sample likely does not enable bypassing the rules. There is an element of luck in small FedEx, UPS, DHL shipments if they do or do not pass through a FDA check.
Once a year importers of medical devices need to fill out FDA form 2891.
Check out: http://google.fda.gov/search?client=...*&q=2891&as=GO
You must also fill out Form 2892 for each product type you ship to the US. This only needs to be done once.
Check out:
http://google.fda.gov/search?client=...*&q=2892&as=GO
You must have a US agent.
http://google.fda.gov/search?client=...&q=agent&as=GO
It is possible that your product is exempt from 510K requirements.
http://www.accessdata.fda.gov/script...fm?GMPPart=886
These are amateur comments to try to help. I offer no assurance of accuracy.
All manufacturers, exporters, re-manufacturers, etc of lenses, eyewear and sunwear must be registered with the FDA otherwise the product will be held no matter what quantity you send to the US. If you need help with the forms just message me. The forms are in FDA English and can be confusing.
Doc
Doc is right,
Myself being a manufacturer of chemicals to the optical industry can give you some information:
Spectacles Frames, Lenses, ect do belong into the category medical devices and are under the jusrisdiction of the FDA. Everything that is added to frames and lenses is falling under the medical device category.
Each US border point has customs officers as well as FDA agents. As soon an object crosses the border and is cleared through customs, the customs officers might decide or suspect that the item is a so called device it is handed to the FDA agents.
The FDA agent checks if the sender is a properly registered device manufacturer. If not the parcel is refused entry into the USA.
In order to supply into the USA you must be a registered davice manufacturer and you must have an initial distributor, which can be youtself with your customs broker address.
The FDA claims that they do not have enough manpower to check all device manufacturers in the US so at least they can control the ones the ones outside the USA. Therefore some products made outside the USA must comlpy with the rules while the same products made in the US do not.
Therefore registration with the FDA is a must if you want to supply into the USA.
Thank you for your remind.:)
That mean I'm bad luck. I need to get back the parcel and I may send it throught Speedpost.
[QUOTE=TOPSKYINT]
Thank you for your remind.:)
That mean I'm bad luck. I need to get back the parcel and I may send it throught Speedpost.
[/QUOTE
Even speed posy is taking a chance. Sped post will also go through customs and parcel ,might be blocked. Register with the FDA and you will be OK.
Chris is totally correct. If you want to do business in the US, follow the links above and fill out the forms. You do not want to get listed as someone avoiding the rules.
If you have traditional eyewear products - prescription frames, sunglasses and readers as examples - I believe all you need is form 2891, a US based agent, and a form 2892 for each product type.
The time to fill out the forms is nominal. There are time lags before you will receive confirmation of approval so do not delay.
If you need help, email me at impact500@aol.com
Thank Chris and Impact5000. I will both of this at the same time. Using speedpost because I used it to send sample to US before. The client push me:(.
I'm studying the form. Need one months for confirmation ? and How much of the registeration?
Lawrence,
Registration is free!
Doc
Thank you. Doc.
a US based agent,
Watch out this id very often a scam. Those peple or companies that offer themselves as agents for the FDA charge often a few thousand dollars per year for doing nothing.
I have asked a lawyer if he could or wanted to be my agent towards the FDA and the answer was yes. To my question "for what price?" the answer was nothing, as long as there are no problems and then you will be charged the normal hourly fee.
So far in 24 years I never had a problem with the FDA and since there is an agent required it has cost me nothing for the agent either.
Good point Chris. I know many manufacturers in Asia that have the same registered US agent and payed alot of money. If a company outside the US needs a US based agent its easy enough to find a free or relatively free agent. i.e. an existing customer or a US company that you have a relationship with.
Doc
What does it take to become an agent?? Are there any forms or fees??
On the FDA form 2891 it asks for the contact person or company in the US. It is as simple as that. I would recommend that if you want to be an agent for an overseas company that you register your own company with a seperate form 2891 (and register as an importer).
Doc
Jaqui, Doc is right, there no problem and only a formality. However if there is an accident claimed to be originated by the product...........a complaint.........or any other irregularity between the FDA and the registered manufacturer, who might have disapeared, gone bancrupt or just not renewed his yearly registration, which as of now will be done by internet.
At such a point the agent will be responsible to get everything cleared up which could involve some work.
i know this is a very old thread, but i have a question and hope someone can really help me, all these # & certificates are aiming at products that's importing to the U.S., what about American made sunglasses ?? do they need these tests too ??
i know this is a very old thread......................
Everything is under the same umbrella...............however as stated before in this thread, the FDA has no time to worry about the USA manufacturers. I guess that would be until some complaint is launched against one of them who is not registered, and then he would be fined.
How can I contact Connie Poon, can you provide contact details
Conni Poon might be out of this job, married or too old to work as this thread 8 years old.
The manufacturer or supplier need to be FDA registered to export optical good to the USA
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