Legal Manufacturer Medical device

#1
Hi,

My client wants us (our company) to become the legal manufacturer for software medical device and he (Client) will hold the IP and distributorship? It would be helpful, if you through some light on various options available to support my customer requirements and avoid product liability on my company? Do I still need to register with FDA as a contract manufacturer?
 
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yodon

Staff member
Super Moderator
#2
I got a bit lost there. If your client is holding all the IP and is the distributor, what is your role exactly?

The "legal manufacturer" is the entity whose name is on the product and who is ultimately responsible for regulatory compliance (and product liability).

If I try to read between the lines (and I may well be wrong), it sounds like you're the contract software developer? If that's the case, they need to drive whatever requirements (e.g., 62304) onto you. There may be some contractual arrangements for fixing problems after release.
 

Watchcat

Trusted Information Resource
#3
It is important to understand that "legal manufacturer" is not an FDA term. It is an MDD/MDR term which I'm guessing is where you and/or your client picked it up. FDA uses the term "manufacturer" differently across different regulations, which is why it is important, when reading the regulations, to pay close attention to Scope and Definitions. As far as registering goes, FDA requires "establishments" that are engaged in one or more specified activities to register, including contract manufacturers:

Who Must Register, List and Pay the Fee

Also, in the US, "product liability" refers to lawyers filing lawsuits that will be addressed by the courts. Registering with FDA will give the lawyers and courts a way to find you, but probably you mean "regulatory liability," which involves FDA, warning letters, consent decrees, debarments. Registering with FDA will give it a way to find you, too, for these kinds of thing, but also for inspections, and correspondence.

If you are going to register with FDA, I strongly recommend you secure the services of a medical device lawyer and/or a regulatory consultant. (Full disclosure, I am the latter.)

I personally would start with the latter, as we typically have a broader perspective on dealing with FDA, and, all things being equal (e.g,, size of firm = amount of overhead), we tend to be a bit less expensive than a lawyer. Also, we can help you identify specific issues for which you need a lawyer, if any. [I say all this with some trepidation, because of course there are good and not-so-good practitioners of both the legal and regulatory arts. So, better a good lawyer than a bad RA consultant, even though a lawyer per se would not be my first go-to here.]
 
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