Register, list and pay the Device Facility User Fee with FDA

M

MgAcer

#1
Hi all,

Our customer (U.S. company) requires us (E.U. company) to register, list and pay the Device Facility User Fee with FDA. :confused:
This is a surprise for us, as since 2004 we have been working with this company and there is no changes on products or specs.


We are approved supplier of the U.S. company. We supply them and manufacture under their specifications medical instruments packaged and labeled under class I (exempted), and the U.S. company is who puts on the U.S. market and distributes under it's name and trademark the medical instruments.

There is no information about our compnay on labels or product sheet as manufacturer..:nope:


My question is: Should our company register, list and pay the Device Facility User Fee with FDA?

Thanks!
 
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harry

Super Moderator
#2
My question is: Should our company register, list and pay the Device Facility User Fee with FDA?
I see this as a basic business decision - is it worth it? I mean not just dollars and cents but look at the potential also.

I believe the other party had done their maths.
 
M

MgAcer

#3
Many thanks for your post..

We are a small business, the products are low target margin and $1,851/year and pay for an U.S. Agent, hurts.

I really mean if we must (is required by U.S. laws) register, list and pay the Device Facility User Fee with FDA.
 
B

brahmaiah

#4
Hi all,

Our customer (U.S. company) requires us (E.U. company) to register, list and pay the Device Facility User Fee with FDA. :confused:
This is a surprise for us, as since 2004 we have been working with this company and there is no changes on products or specs.


We are approved supplier of the U.S. company. We supply them and manufacture under their specifications medical instruments packaged and labeled under class I (exempted), and the U.S. company is who puts on the U.S. market and distributes under it's name and trademark the medical instruments.

There is no information about our compnay on labels or product sheet as manufacturer..:nope:


My question is: Should our company register, list and pay the Device Facility User Fee with FDA?

Thanks!
Revise your prices upwards and pay what ever fee they want
v.j.b
 

harry

Super Moderator
#5
if we must (is required by U.S. laws) register, list and pay the Device Facility User Fee with FDA.
Not that I know of - but my information is dated. Regular Covers should be able to update us.
 
M

MIREGMGR

#6
My perception would be that this is not about your direct costs. The outlined actions would position you, implicitly at least, as the FDA Manufacturer of the medical device(s) you sell them. Your customer would be only a distributor. You would have full regulatory responsibility and at least most of the medical-legal-liability exposure. They would have essentially none of the former, and much less of the latter.

Is that the allocation of regulatory and legal-liability responsibilities you intend in your relationship?

Of course, the specific language of your contract with your customer, if any, could conflict with the above analysis...but in the instance of such a conflict, regulatory registration would carry considerable weight in establishing who is responsible in the event that a problem should occur.

Perhaps your customer does not maintain an FDA-acceptable quality system, or wants to cease maintaining one, and someone with knowledge of the regulations realized that if they could suitably clarify their relationship with you to identify you as the Manufacturer, they would be off the hook regulatorily.
 
C

Chris Ford

#7
Hi all,

Our customer (U.S. company) requires us (E.U. company) to register, list and pay the Device Facility User Fee with FDA. :confused:
This is a surprise for us, as since 2004 we have been working with this company and there is no changes on products or specs.


We are approved supplier of the U.S. company. We supply them and manufacture under their specifications medical instruments packaged and labeled under class I (exempted), and the U.S. company is who puts on the U.S. market and distributes under it's name and trademark the medical instruments.

There is no information about our compnay on labels or product sheet as manufacturer..:nope:


My question is: Should our company register, list and pay the Device Facility User Fee with FDA?

Thanks!
I can't see what you would list with FDA since you don't own / distribute the product, but you are required to register your establishment under 21 CFR 807.40.

You can see the regulation here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.40

You should register the establishment as a contract manufacturer, in my opinion.

Here is a link to some "user friendly" language regarding the listing process.

http://www.fda.gov/MedicalDevices/D...YourDevice/RegistrationandListing/default.htm
 
C

Chris Ford

#8
I can't see what you would list with FDA since you don't own / distribute the product, but you are required to register your establishment under 21 CFR 807.40.

You can see the regulation here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.40

You should register the establishment as a contract manufacturer, in my opinion.

Here is a link to some "user friendly" language regarding the listing process.

http://www.fda.gov/MedicalDevices/D...YourDevice/RegistrationandListing/default.htm
This is very common by the way. Many manufacturers and contract manufacturers are not aware of the registration requirements. This is usually caught either during an internal audit or an FDA inspection. It's possible the lack of registration was discovered during import, as well.

That explains why you've done business with this company for several years without this requirement. But, since it's a new requirement, why not take it back to the customer in the form of a price increase?
 
M

MIREGMGR

#9
Clearly Chris Ford and I are arriving at different understandings of your original post. If he is correct, I agree that the "listing" request is confusing, but the overall request is much more straightforward in regard to its regulatory and liability implications for you.

Perhaps you could post again and clarify whether your customer wants you to be their contract manufacturer, or the Manufacturer.
 
M

MgAcer

#10
Thank you all for your posts!

Well, I asked our customer why now (we've done business since 2004) requests our company to be FDA registered, and says that will arrange a conference call next week to provide us more background information on what is driving the need for some of their EU based suppliers to be FDA registered..

Maybe, as posted, they want to become only a US distributor or/and due to a FDA inspection they does not maintain an FDA-acceptable QS.

I'm not afraid, as our small business is EU approved manufacturer by the Spain's Agency (CE 0318) notified body for sterile/non sterile medical devices class I and II.

Also, we would have to increase pricing due significant responsibility increment.

Anyway, I let you all updated next week.
 
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