What are these Medical Device Company entities?

[pecuniadelictumest]

I am in the process of establishing operations to market a medical device, and the requirements for registration, as they pertain to my organizations, are a bit hazy. Here are the responsibilities of my organizations:

• Company 1
• ​
  Markets a medical device under their own name. However, no specification development, design activities, manufacturing, or distribution are handled by Company 1. Company 1 has a licensing agreement with Company 2 to market the devices and Company 3 handles all manufacturing and distributing activities.
• Company 2
• ​
  Develops devices, including specifications, design control, 510(k) submissions, etc. However, all manufacturing activities are handled by Company 3, and all marketing activities are handled by Company 1.
• Company 3
• ​
  Manufactures devices per the requirements set out by Company 2.

I am looking for clarification concerning the definitions of these companies in order to ensure compliance with the listing and registration requirements.

 

[MIREGMGR]

Re: What are these entities?

There are a couple of possible interpretations of your brief outline. In one interpretation:

#1 has primary regulatory responsibility for the medical device.

#2 is a contract designer/specification developer.

#3 is a contract manufacturer.

The "licensing agreement" comment however is confusing in this regard.

In another interpretation:

#1 is a Private Label marketer, therefore is not responsible for the device. As a Private Label marketer, their formal role is Distributor, even though they do not do the physical distribution.

#2 has primary regulatory responsibility for the device, as the Specification Developer.

#3 is a contract manufacturer.

Which of these applies, hinges on what the agreement between #1 and #2 says.

 

[Mark Meer]

Re: What are these entities?

Does the fact that company #2 appears to be the 510k holder have any bearing?

Wouldn't this lean towards MIREGMGR's second interpretation?

 

[MIREGMGR]

I interpreted the original post as saying that #2 prepared 510(k) submissions. This would not necessarily result in them being the 510(k) submitter of record and resulting 510(k) holder, if their submission preparation work was done under contract, much like their design/spec-development work.

In any case, if one accepts precedent as more determinative than their rather confused body of rules and guidances, FDA does not require the marketer of a device to be the 510(k) holder. I have heard of instances in which a contract manufacturer holds the 510(k) for a marketed device.

I generally don't regard who holds the 510(k) as being solely sufficient for determination of regulatory responsibility in a vaguely defined marketer/maker relationship.

 

[Mark Meer]

I generally don't regard who holds the 510(k) as being solely sufficient for determination of regulatory responsibility...

Interesting. Admittedly, I'm not well versed on FDA precedent, and the details of regulatory responsibility in multi-company relationships...but one would assume that because the 510(k) is essentially an attestation of substantial equivalence, including all supporting evidence, that when the FDA approves a 510(k), it is the owner of the 510(k) that would be responsible for ensuring the continued safety and efficacy of the device, as per details presented in the 510(k).

Perhaps I'm confusing what is meant by "regulatory responsibility"....

 

[MIREGMGR]

Oh, I agree that when someone other than the marketer and Lister of a device "owns" the 510(k), it makes for an unclear responsibility situation. But, such is the FDA legacy.

Anyway, in the immediate situation, we need more details on #1 and #2 to clarify who's responsible.