US Customs importation help/ Accession Number application

[darryl zero]

Hi all, new to these forums.

Have been bringing in some red laser sights from China for a while now. Class IIIa, power output below 5mw. Super cheap, standard laser pointer stuff, nothing fancy, nothing illegal.

Most recent shipment was stopped by customs. 35 pcs, total value about $300. They are asking for accession numbers, which of course I don't have, and neither does the manufacturer in China or the middleman I went through.

Submitted FDA form 2877 and checked the box RB2 of Declaration B on form 2877, "evidence of certification label on each product" (each laser has the standard "class IIIA laser, power output less than 5mw, 650nm). I don't know if this will be good enough for customs, but didn't know what else to check off. The pessimist in me thinks the parcel will be sent back to China.

Now I'd like to continue bringing these in on the regular, and seems like I'll need to get accession numbers for the lasers. As I understand it, I the importer can apply for accession numbers, I just need to fill out the online eSubmitter and apply for them with the FDA. Supposedly the process takes about an hour?

I'm completely clueless as to how to do this application process though. Has anyone done it or can help guide me? Not tech savvy regarding lasers, no idea how to fill this thing out.

Any help?

 

[Encap]

I assume you buy them to resell them because of the quantity.

You better get some professional help to be able to comply with all the regualtions if you are the manufacturer for FDA purposes---the US person importing become the manufacturer under FDA rules. You will also then becomoe responsible for following all the requirements of FDA for the product also---accession number is the least of it.
Lasers in the USA are governed by specific rules and regulations listed in the Code of Federal Regulations, 21 CFR 1040.10 and 1040.11.
Lasers that are brought into commerce in the USA (sold, imported, exported or USED) in the USA are REQUIRED BY LAW to meet minimum safety requirements set forth by the above CFR (Code of Federal Regulation).

Laser systems do not need to be "registered" per-se with the government. Instead, manufacturers must submit a product report which can be found http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081592.pdf. The product report describes how the manufacturer or person introducing the laser into commerce demonstrates that it meets the minimum requirements for safety. Until that report is submitted AND APPROVED (e.g. you receive an accession number or “variance” issued by the CDRH) the laser system is NOT "legal."
Once it is legal, the laser is also eligible for re-sale, as long as the re-sale guidelines are met also.

THe original manufacturer in China if you can determine who it actually is iresponsible for having gone through the process and received an accession number for the product---if they did not do then it is illegal for them to ship to USA. MAybe better for you to buy from a manufacturer that already complies with the US rules and regulations.

 

[LSRFAQ]

1. You basically created a circular argument, you checked the box "see the accession number on the label" but there is no accession number on the label.
Customs went to look at the label and found no number.

2. There probably is no accession number on file for the device. An accession number is not a approval per se, it is a reference to use with the FDA for communications purposes. The first time you communicate with FDA officially about the device, you will get assigned a number. That does not mean you have approval to market or import.

3. The Chinese get this wrong often. They get a letter with an accession number as a automatic reply and think they are done with the US Government. They think this means they have approval, when in reality its just step 1.

4. You need a variance number or other code assigned by FDA to import. You don't have it, and the nice lady they just hired in DC to check these things is very vigilant.

5. Its a gun sight, and lately the USG has been very touchy on these. Anecdotally I know they have cracked down on sight manufacturers.

You need to contact CDRH, get the document packet from them. File a product report, and institute a quality control program and record keeping per 21 CFR 1040. This means inspecting each device, checking a sample quantity from each batch with a laser power meter, insuring the labeling is correct etc. You may need to retain records on who you ship them to, in case of recall.

Takes about 30 days. CDRH is a small agency, and responsible for a lot more then lasers. It really, really, really helps if you call them. Their day starts early in the morning Eastern time, so they are often out of the office by 3:30. If you work out a plan with them this gets easy. They actually can be helpful as one of their mandates is to ensure commerce.

A funny thing about product reports, they can be quite simple. Yours might only be a few pages, double spaced typed with almost no technological language. They WILL work with you in DC, if you can get ahold of them.

Before you think you need a megadollar LPM for the QC, in your case it might be a cheap go/no go tester with a calibrated solar cell etc.

Steve

 

[darryl zero]

In my haste to see what I thought were rather innocuous items released, I thought that the presence of the "danger, avoid eye exposure / laser radiation/ class IIIa 650nm output below 5mw" label was the certification label asked for on form 2877. Further research makes me think no, that is not a satisfactory label... Though am I mistaken in thinking that a simple label that says "conforms with the provisions in FDA CR.1040..." Etc. WOULD have been sufficient?

Regardless, DHL informs me that there is a 7-10 day FDA hold on my parcel (which is more involved than a 3-5 day FDA review). The DHL rep was baffled and said they were surprised the lasers were stopped at all given that power was below 5mw and literally millions of laser pointers are being shipped into the US everyday for sale at 99 cents stores. They speculated (off the record) that someone at customs made the decision on day 1 that these weren't gonna get through and are now looking for a missed dotted I or crossed t so they can send the parcel back to China... Which in the absence of accession numbers, is a given.

 

[LSRFAQ]

Darryl Zero,

Check your PMs, phone # enclosed is NOT for publication. It took me a long time to get that number and I'll be damned if I contribute to it getting changed again!

Steve

 

[LSRFAQ]

I don't think gun sights are in the blanket low power IIIA exemption that used to be in force. You may need approval.

Sorry your the one in the million, but I expect a LOT more of this.

FDA recently really, really, really, asked Customs for help with enforcement.

After all, a sticker does not constitute approval or certification.


Steve