Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

F

fpindustries

#1
We've imported "pleasure" toys into the US for more than a year now, but our latest shipment is in detention, with the following problem/problems:

502(o), 801 (a)(3) misbranding

that the device or devices are subject to listing under 510(j) or (k) and that we have not pre-registered the devices, or ourselves as the initial importers.

The devices are dildos, vibrating dildos, male masturbation cups, etc. Not what we thought was subject to FDA regulation as "medical devices".

Anyone have any experience in this area or know someone who does?

NOTE: Although this discussion is over 6 years old, Google is now making more changes to it's "review" algorithm and has "flagged" this discussion. They are not human reviews. If they were, it would be obvious to them that simply having the words "sex toys" in a discussion does not, or should not, classify this discussion as "Adult: REDACTED Content" yet Google has sent an "Your AdSense Publisher Policy Violation Report" to us despite the fact that it is solely related to medical device classifications. Because this discussion contains information solely related to Medical Device classifications we have decided not to remove the thread.
 
Last edited by a moderator:
Elsmar Forum Sponsor
G

Gert Sorensen

#2
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

I think you have run into this classification with the FDA:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3487

Basically what it says is that your devices are defined as Class 2 and that they are not exempt from GMP requirements.

In order to market them legally in the US you will need to be registered with the FDA and submit a 510k application to establish equivalence with an already marketed product that is similar in design and function. On top of that you need to have a quality system in place that is in compliance with 21 CFR part 820.

:bigwave:
 
M

MIREGMGR

#3
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

Pieces of wood of particular shape and dimensions can be medical-device-tongue-depressors, or paint stirrers, or disposable spatulas, or several other things. Marketing intent does matter to regulatory applicability. When it can be shown that there is a long history of the same product being legally marketed primarily as a non-medical-device and to a much lesser extent as a medical device, an argument obviously should be possible that a Customs decision as apparently has occurred was not handled properly.

It's possible that some paperwork related to your shipment was less-than-optimally filled out, leading to the chain of decisions that got you where you are. If that was the case, you might have to take some financial lumps.

In any case, to manage this situation, you need a law firm that specializes in customs and regulatory matters. We can't really help you here with the legal issues.
 

Wes Bucey

Quite Involved in Discussions
#4
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

Pieces of wood of particular shape and dimensions can be medical-device-tongue-depressors, or paint stirrers, or disposable spatulas, or several other things. Marketing intent does matter to regulatory applicability. When it can be shown that there is a long history of the same product being legally marketed primarily as a non-medical-device and to a much lesser extent as a medical device, an argument obviously should be possible that a Customs decision as apparently has occurred was not handled properly.

It's possible that some paperwork related to your shipment was less-than-optimally filled out, leading to the chain of decisions that got you where you are. If that was the case, you might have to take some financial lumps.

In any case, to manage this situation, you need a law firm that specializes in customs and regulatory matters. We can't really help you here with the legal issues.
My experience with bureaucratic red tape over the years matches MIREGMGR's insight here. In the quality profession, we have a process termed Failure Mode & Effects Analysis (FMEA) - essentially we brainstorm about what could possibly happen to derail our processes from being efficient, effective, and, hopefully, profitable. Then we plan "workarounds" to reduce the risk of them happening or to ameliorate the damage if they DO happen.

Often, when bureaucrats get involved, it is because the "letter of the law" was not followed and some petty satrap has noticed. If your current paperwork is identical to your paperwork on past successful shipments, it means the other government inspectors were not as sharp-eyed as the one who impounded or detained your shipment. If the paperwork is different, the remedy is the same:
You probably want to have a savvy law firm plead your case to amend the paperwork to free your goods. I emphasize savvy because inexperienced practitioners will lose a lot of time learning the ropes. The very fact you are asking in this forum is a strong clue you do not have the experience to do this quickly and time is usually your biggest enemy.

I'm sorry to say the savvy law firm will not be cheap, but it will surely be cheaper than losing the entire shipment. The upside is all future shipments will then have the proper paperwork and the problem will not repeat.
 
F

fpindustries

#5
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

Wow, first time poster here, and just wanted to say thanks to you guys for being so helpful. I did my own research, but was unable to find that genital vibrators for therapeutic uses were regulated under the statute.

I found a company/lawfirm which specializes in these issues, so will be contacting them today to help me get it sorted. I do wish though that my shipping/customs clearing agency would have notified me of this in the first place... :( :argue:

You think the FDA will allow us to file the 510(k) paperwork at this time and wait for an approval before they release?

I'm already counting up what the "storage fees" will be... :mg:
 

Ronen E

Problem Solver
Staff member
Moderator
#6
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

You think the FDA will allow us to file the 510(k) paperwork at this time and wait for an approval before they release?
That would be like actually admitting that these are in fact medical devices and subject to FDA regulation, now wouldn't it?... So it will deny you the "oops" option, I reckon ;)
 

Wes Bucey

Quite Involved in Discussions
#7
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

That would be like actually admitting that these are in fact medical devices and subject to FDA regulation, now wouldn't it?... So it will deny you the "oops" option, I reckon ;)
Yep. Effort should be toward amending paperwork to show they are exempt because they are non-medical devices (toys or novelties.) The medical device designation calls up a whole bucket of worms in getting the manufacturing site certified to cgmp (current good manufacturing practices) and subsequent periodic inspection of those facilities.
 
F

fpindustries

#8
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

yes, i agree, and i figure the law firm's goal will be the same. it really must depend on the inspecting officer... i can't imagine that every sex toy importer has filed medical device paperwork....
 
T

True Position

#9
re: Our container of pleasure toys is stuck... regulated as "medical devices" by FDA ?

That would be like actually admitting that these are in fact medical devices and subject to FDA regulation, now wouldn't it?... So it will deny you the "oops" option, I reckon ;)
Yet, if classified as a medical device there there is the potential for medicare and medicaid reimbursement.

NOTE: Although this discussion is over 6 years old, Google is now making more changes to it's "review" algorithm and has "flagged" this discussion. They are not human reviews. If they were, it would be obvious to them that simply having the words "sex toys" in a discussion does not, or should not, classify this discussion as "Adult: REDACTED Content" yet Google has sent an "Your AdSense Publisher Policy Violation Report" to us despite the fact that it is solely related to medical device classifications. Because this discussion contains information solely related to Medical Device classifications we have decided not to remove the thread.
 
Last edited by a moderator:
M

MIREGMGR

#10
If you want to market these products as se x toys, I suggest you DO NOT proceed with your described plan of registering/listing/filing for them as medical devices.

Once you had registered as a medical device marketer, it would be much more complicated for you to be a marketer of the (apparent) same product via non medical device channels.

I suggest you not do anything until you have guidance from your lawyer.

I think that guidance will be that it's legally and regulatorily complicated for a single company to be both an apple and an orange at the same time, and your existing company should stick with whatever it's already set up to do.

You then could consider setting up a second company for the separate market, as a project that's separate from resolving your Customs issues.
 
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