Importing Machine held up by FDA

[Scott Shepherd]

Hi. Daniel. I musta got lucky I didn't use a broker. I contacted my Manu they sent a doc that I put with my form. Received my laser 4 days later.

The problem is it's Chinese New Year, so everyone is closed until that's over.

[Neville Stewart]

My broker did mine too - I sent them the info from Weike and they did the rest.

And thanks a million for doing that Gary - having a ball with my Fiber.
Stewart.jpg

[Gary Hair]

Nice work Neville!

[Neville Stewart]

Nice work Neville!

You've only taught me 99.9% of it : )

[Gary Hair]

Glad you came up with the .1%, I can't give you everything...

[David Somers]

Neville,

Just curious what the material is that you show in your photo? I assume that was engraved on your Fiber? How long does that take to engrave?

Very nice looking!

Dave

[Neville Stewart]

Hi David, its 6061 Aluminum, run on a 3 hatch pattern on a 30 w Fiber for about 60 mins or so. The hatch was sequential so it could have been done in about 40 I would say.

[Matt Geraci]

When my fiber was about to ship they had that big military parade through Beijing a few months back. Mine was in a crate on the dock for 4 weeks - they didn't let anything ship out of country during that period!! Luckily once it left TNT and DHL did a great job getting it to me with little delay

[David Somers]

Neville

So. How big is that piece you did? The engraving looks fairly deep? Was that a one off product or part of a larger run. What do you expect to charge for a single
Object that takes an hour to run? Just curious. I hadn't paid much attention to fiber galvos but now you have me curious about them. Not that I have enough time to play with all my existing toys right now. Grin.

[Neville Stewart]

The piece is about 1.5 inches x 1 inch and it's just a test piece for power parameters/hatch pattern/selection. It's hard to say what I'll charge right now but you know gun owners, I have a lot invested in mine anyway. Fiber lasers with an expected 100k hour life have to be thought of differently I suppose. Perhaps some seasoned users could address the topic of cost. I know another user that charges by hour and has no issue getting it.

[daniel coyle]

Well, I got lucky. I had to get creative, and I have to leave it at that (PM me if you want specifics). I was able to send the FDA an accession number and an explanation about it that they accepted. Had I not pushed the envelope here in the way I am not describing I was promised by the FDA that the machine would be destroyed with no recompense. I had hired a broker that I had used in the past successfully and she did not know about accession numbers. I hired her because I did not expect that I could know and manage all the details of importing myself (thought I was being responsible and thorough by hiring an expert to handle it). This was a broker who was recommended to me here on this forum. Of course I wish she had been more competent but she is in my opinion fundamentally responsible and reliable and after going through this it seems this part of the FDA's procedures is exceptionally challenging (understatement) for a small business person to negotiate and very easily missed by all but the most specialized/experienced brokers.

Some manufacturers have these numbers and some don't, the FDA does not share the ones who do and don't (which is unhelpful to say the least), the manufacturers who don't have this number may or may not know they need it and there is no barrier to them making the mistake of sending a machine without it. What's more, that there is no other process in place by the FDA but to destroy machines that don't have the number is bleak.

The accession number is assigned by the FDA to Chinese companies after they fill out a form stating that their machine is radiation safe. The FDA may or may not inspect that company later and validate the claim. So, the accession number is often a "safety guarantee" by the FDA that was policed, essentially, by the Chinese manufacturer whose primary interest is selling machines and not safety of international users.

That the FDA doesn't offer to make one pay for an individual inspection or even a fine of some sort while giving one the chance to prove the product's viability is really minimalist and does not address the complexity and vulnerability that already makes up the import process.

I say this all so that, should someone else be looking for advice or feedback, they will hopefully find this and be better prepared to avoid this potential cliff themselves. I feel extremely fortunate to have gotten out without loss but if you heard my story you might be surprised that I did. I may be missing something here, in fact I am sure I am, and I am happy to hear any feedback. Obviously I am biased after going through this and would probably not even have looked at a thread like this had it not been my problem (so, thanks so much to those of you who offered time to help out.)

[Rich Harman]

Well, I got lucky. I had to get creative... ...Of course I wish she had been more competent but she is in my opinion fundamentally responsible...

Do you blame the broker for the problem, or the manufacturer? If the solution required was "creative", I am wondering if the broker had no other options.

[Jerome Stanek]

Aren't the brokers bonded and insured for these kind of problems. We had a trade show display that was held up at the Canadian border and the broker said it wasn't their problem but took them to court and they had to pay to get it back here. They filed the wrong forms when it was shipped to Canada and on the way back is when the problem arose.

[Steve Morris]

Do you blame the broker for the problem, or the manufacturer? If the solution required was "creative", I am wondering if the broker had no other options.

I'd blame the FDA for operating such a poorly designed and administered system that allows people to lose large sums of money due to the FDA's lack of communication and information. Typical government behaviour in my experience.

[Jerome Stanek]

If you read the descriptions on some of the lasers they state that they are FDA compliant. So the brokers should be held responsible for getting it here. That is what you are pating them to do.