Medical Device Contract Manufacturer Registration

[MIREGMGR]

In Reply to Parent Post by Ronen E

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]

In Reply to Parent Post by MIREGMGR

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?

[sreenu927]

Nice discussion!!

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

Thanks,
Sreenu

[Ronen E]

In Reply to Parent Post by sreenu927

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.
...

[ramez75]

In Reply to Parent Post by MIREGMGR

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"

[MIREGMGR]

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.

[Ronen E]

So I'm a bit confused:

That was my argument to XYZ but they say they are not shipping it to US since they ship it to LMN

If that was the basis for XYZ's refusal to register, but they DO ship to the USA - isn't the problem solved?

[csterling]

This is a very insteresting thread...
I hope my question does not deviate from the focus of the original question.

We are a contract manufacturer and would appreciate any feedback related to MDR (medical device reporting). As contract manufacturer are we responsible of filling out the MDR report form 3500A or is it the responsibility of the MDD (owner of the device) in the case of any event in the field?

I am working on the incident reporting procedure and would like to have this aspect clear to ensure proper steps to follow are indicated.

Thanks in advanced for all the repplies.