Medical Device Contract Manufacturer Registration

[ramez75]

In Reply to Parent Post by treesei

This is very interesting. However I need some help with the roles (my thanks in advance):

XYZ owns the 510k of the product. Does this mean XYZ owns the specifications as the product developer (even it acquired the product from somewhere)? If so, does XYZ satisfy the CM definition?

It seems that the product is finished at XYZ. Can ABC call itself the manufacturer of the device by definition? It obviously did not develop the specs. Should ABC be a relabeler (only that it is a virtual relabeler since the practice is done by XYZ) (so XYZ may be a "contract relabeler" )?

By the FDA:

Contract Manufacturer - Manufactures a finished device to another establishment's specifications.

Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name

PS: Every once for a while we will see some discrepency among FDA's documents partially because regulatory is a changing world.

treesei,

XYZ owned the design/technology of the product till it was purchased by ABC years ago. ABC kept XYZ as the manufacturer. So ABC aquired the rights to the product. I know there is a 510k but I have to find out who initiated it, etc. I dont know if that answers your question.

[treesei]

In Reply to Parent Post by ramez75

treesei,

XYZ owned the design/technology of the product till it was purchased by ABC years ago. ABC kept XYZ as the manufacturer. So ABC aquired the rights to the product. I know there is a 510k but I have to find out who initiated it, etc. I dont know if that answers your question.

ramez75,

Yes you did. Thank you. In this case, XYZ is a CM. Since ABC bought the technology, it seems to me that ABC is a spec developer and is responsible for the 510k maintenance. XYZ as a foreign CM must register and list the product if XYZ ships the product to US.

[MIREGMGR]

Things get messy when a 510(k) sale is involved.

XYZ had to have been a Registered Establishment when the 510(k) was issued. If they're not registered now, they must have let that registration lapse.

I assume that when you purchased "the design/technology of the product", you also explicitly purchased the 510(k). If not, things get even messier.

Under current law, a 510(k) held by a company that lets its registration lapse may become void. It's not clear whether that 510(k) can be rejuvenated by re-registering.

If you putatively bought the 510(k) from XYZ, and XYZ was not registered at that time, it's possible that no 510(k) exists. If you didn't buy the 510(k), and XYZ is not registered now, then it seems certain that no 510(k) is in effect now.

Regarding LMN...you earlier described them as ABC's European distributor, but now you describe them as ABC's European Authorized Representative. If XYZ delivers only to LMN, and LMN ships to ABC in the US, then it's possible that FDA might conclude that LMN is the contract manufacturer of record...since they export the product to the US...and XYZ is only a subcontractor.

It's very hard to convince FDA that a supplier has some degree of regulatory responsibility for a product you're marketing, such as that of a contract manufacturer, if you don't have a clear written definition of the business relationship, and that supplier explains to FDA a plausible alternate construction of the plain facts of the relationship and says that that's been their understanding.

Note that in that scenario, the 510(k) question goes out the window.

You said in an earlier post that FDA had held at least one shipment. It was implied that you were able to get them to release it. What did you tell them that caused them to do that?

[ramez75]

In Reply to Parent Post by treesei

ramez75,

Yes you did. Thank you. In this case, XYZ is a CM. Since ABC bought the technology, it seems to me that ABC is a spec developer and is responsible for the 510k maintenance. XYZ as a foreign CM must register and list the product if XYZ ships the product to US.

That was my argument to XYZ but they say they are not shipping it to US since they ship it to LMN (Authorized Rep of ABC based in Europe) and LMN ship it to US. I told them it doesnt matter because they are still the manufacturer of the product

[treesei]

ramez75,

I would suggest that you for the time being put aside the registration debate and focus on the 510k story first. You may want to figure out the whole story of this 510k as well as the relationship/roles of ABC and XYZ. Then it should be more obvious to see how each facility falls into the FDA definitions regarding registration and listing.

[Ronen E]

In Reply to Parent Post by MIREGMGR

Under current law, a 510(k) held by a company that lets its registration lapse may become void. It's not clear whether that 510(k) can be rejuvenated by re-registering.

Could you please kindly specify or point to the legal clause(s) detailing this topic?

Many thanks in advance,
Ronen.

[MIREGMGR]

I don't know of any specific FDA writing that bears on the issue, one way or the other.

What I said, however, is how it's been explained to me by a person with more legal knowledge than me. Note however that I'm not a lawyer and my comments are not competent legal advice. Please assume that I might be right or I might be wrong.

Anyone for whom these nuances may significantly matter would (in my opinion) be well advised to obtain regulatorily qualified legal counsel.

[Ronen E]

In Reply to Parent Post by MIREGMGR

I don't know of any specific FDA writing that bears on the issue, one way or the other.

What I said, however, is how it's been explained to me by a person with more legal knowledge than me. Note however that I'm not a lawyer and my comments are not competent legal advice. Please assume that I might be right or I might be wrong.

Anyone for whom these nuances may significantly matter would (in my opinion) be well advised to obtain regulatorily qualified legal counsel.

I did a little search, which wasn't very conclusive. the closest thing I found is:

5. What are the consequences for failure to pay the establishment registration fee?

If you are one of the types of establishments that are required to pay an establishment registration fee, FDA will consider your registration to be incomplete and will not accept it until the fee is paid. Further, FDA may not accept submissions from you (premarket applications, premarket reports, supplements, premarket notification submissions, 30-day notices, requests for classification information, or periodic reporting concerning a class III device) until you have paid all fees owed, including all required establishment registration fees. See section 738(f)(1) of the Act, as amended by section 212 of the FDAAA.

(P. 5 of Guidance for Industry and FDA Staff -- Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007; issued on October 8, 2009)

The above clause only states that new submissions will not be accepted; it says nothing about past cleared submissions (and as noted, I couldn't find anything in that regard, which of course doesn't mean it doesn't exist, somewhere). I'd tend to think that if such practice was in place, it'd be at least hinted in a clause discussing the consequences of failure to register or re-register (you're probably aware that initial 510(k) submissions do not require the applicant to already be registered; registration is required only within 30 days of [consequent] commencement of manufacture and distribution). It's true that the cited language relates specifically to failure to pay registration fees, however the context clarifies that failure to pay equals failure to register or lapse of current registration. Therefore, if failure to re-register would result in 510(k) void (or whatever similar-meaning terminology), failure to pay registration fees would have had the same consequence.