Medical Device Contract Manufacturer Registration

M

MIREGMGR

#21
Yes, I noted "theoretically". The company for which I work was last inspected quite a few years ago.

My guess as to why is that the FDA regions are using a scoring system for inspection priorities, and our region knows enough about us, in combination with our long time as a registered establishment, our low risk based on product codes and our zero adverse event incidence, to put us near the bottom of their priority list.

Again a guess, but it's also possible that interactions with FDA are logged via contact reports, and the more questions you ask, the more the scoring system assumes you're conscientious and moves you down the list. We interact with FDA a lot.
 
Elsmar Forum Sponsor
R

ramez75

#22
So this what I found out.

XYZ do not have a 510k. ABC owns and have the 510k. So to recap

ABC is in the USA and owns and have a 510K and is registered with the FDA. ABC also owns the specification.

XYZ is the manufacturer of the product in Europe and is not registered with the FDA.

According to the FDA website they need to register right? So XYZ is a contract manufcaturer to ABC.

Who Must Register
Manufacturers An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for commercial distribution (marketing) is required to register. This includes manufacturers, contract manufacturers and contract sterilizers that place the device into commercial distribution, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose. Foreign establishments (manufacturers and exporters) Foreign establishments that manufacture, prepare, propagate, compound, or process a device that is imported, or offered for import, into the U.S. are required to register their establishments. This includes contract manufacturers and contract sterilizers. Foreign establishments must also list the devices that they export to the U.S.
 
M

MIREGMGR

#23
So XYZ is a contract manufcaturer to ABC.
In an earlier post you said that XYZ ships to LMN, your European distributor. It was implied that all shipments went there, and LMN then shipped part of the total to ABC in U.S.A. I'm assuming that's still the case.

Is the product labeled for U.S.A. and otherwise entirely ready for marketing and end use when it leaves XYZ? I'm assuming yes.

I think the question of whether XYZ is a contract manufacturer is determined by the Purchase Order to them, or possibly a Supplier Agreement with them. If the Purchase Order states that the ordered item is a medical device for the U.S.A., and they accept the P.O., then they must Register.

Note however that it appears they don't have to List, because they don't export the product to U.S.A. Instead LMN would have to List...however, LMN probably isn't Registered, and generally Listing requires Registration. And, someone has to List at the export end, or the product can't cross the border.

I don't think this can be handled with assured correctness according to the published rules. FDA help will be required.

I'm still curious as to how earlier shipments were able to be released by FDA after being held. Nothing that you've told us so far has explained that.
 

Ronen E

Problem Solver
Staff member
Moderator
#24
In an earlier post you said that XYZ ships to LMN, your European distributor. It was implied that all shipments went there, and LMN then shipped part of the total to ABC in U.S.A. I'm assuming that's still the case.

Is the product labeled for U.S.A. and otherwise entirely ready for marketing and end use when it leaves XYZ? I'm assuming yes.

I think the question of whether XYZ is a contract manufacturer is determined by the Purchase Order to them, or possibly a Supplier Agreement with them. If the Purchase Order states that the ordered item is a medical device for the U.S.A., and they accept the P.O., then they must Register.

Note however that it appears they don't have to List, because they don't export the product to U.S.A. Instead LMN would have to List...however, LMN probably isn't Registered, and generally Listing requires Registration. And, someone has to List at the export end, or the product can't cross the border.

I don't think this can be handled with assured correctness according to the published rules. FDA help will be required.

I'm still curious as to how earlier shipments were able to be released by FDA after being held. Nothing that you've told us so far has explained that.
http://www.fda.gov/MedicalDevices/D.../RegistrationandListing/ucm053165.htm#foreign

Mind you, if XYZ is a foreign contract manufacturer who (directly) ships finished devices to the USA, they must register and list. In my understanding, if they only ship to LMN in Europe they are exempt from both. In this latter scenario, LMN may end up as a Foreign Exporter, and then they have to register and list.

Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
 
M

MIREGMGR

#25
In my understanding, if they only ship to LMN in Europe they are exempt from both.
I agree on exemption from Listing. I think they'd still have to Register, though, if ABC's contract for manufacturing is with them.

If on the other hand ABC contracted with LMN and LMN then subcontracted with XYZ, I'd agree with you.
 

Ronen E

Problem Solver
Staff member
Moderator
#26
I agree on exemption from Listing. I think they'd still have to Register, though, if ABC's contract for manufacturing is with them.

If on the other hand ABC contracted with LMN and LMN then subcontracted with XYZ, I'd agree with you.
Reference?

:thanx:
 

sreenu927

Quite Involved in Discussions
#27
Nice discussion!!

Here " intended for commercial distribution" means distributing to the legal manufacturer or distributing directly to customers??

Thanks,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#28
Nice discussion!!

Here " intended for commercial distribution" means distributing to the legal manufacturer or distributing directly to customers??

Thanks,
Sreenu
21 CFR 807.3 (Definitions):

...
(b)Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following:

(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;

(2) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under section 520(g) of the act and part 812 of this chapter;

(3) Any distribution of a device, before the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under section 513(f) of the act:provided, That the device is intended solely for investigational use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premarket approval application as provided in section 515 of the act; or

(4) For foreign establishments, the distribution of any device that is neither imported nor offered for import into the United States.
...
 
R

ramez75

#29
In an earlier post you said that XYZ ships to LMN, your European distributor. It was implied that all shipments went there, and LMN then shipped part of the total to ABC in U.S.A. I'm assuming that's still the case.

Is the product labeled for U.S.A. and otherwise entirely ready for marketing and end use when it leaves XYZ? I'm assuming yes.

I think the question of whether XYZ is a contract manufacturer is determined by the Purchase Order to them, or possibly a Supplier Agreement with them. If the Purchase Order states that the ordered item is a medical device for the U.S.A., and they accept the P.O., then they must Register.

Note however that it appears they don't have to List, because they don't export the product to U.S.A. Instead LMN would have to List...however, LMN probably isn't Registered, and generally Listing requires Registration. And, someone has to List at the export end, or the product can't cross the border.

I don't think this can be handled with assured correctness according to the published rules. FDA help will be required.

I'm still curious as to how earlier shipments were able to be released by FDA after being held. Nothing that you've told us so far has explained that.
After asking questions, I was told XYZ ships directly to USA so take out LMN of the scenario I presented in earlier posts. Yes P.O list the product which is labled as a Medical Device.

I was told that the way they released them earlier is because the product was labeled for "demonstration only"
 
M

MIREGMGR

#30
I'll go ahead and ask because I'm curious as to how inquisitive the FDA's inspectors are, but I don't necessarily recommend that you answer:

the product was labeled for "demonstration only"
Were all the units of product used only for "demonstration", and not for clinical procedures on patients?

The latest version of the scenario is curious because there doesn't seem to be an exception in the Registration rules related to "demonstration use", and I don't see how the PREDICT import documentation requirement could have been met without an Establishment number for the exporter, i.e. XYZ.
 
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