Legal Manufacturer - MDD Definition of "Legal Manufacturer"

M

medic61

#11
Re: Definition of "Legal Manufacturer"

MIREGMGR:
I enjoy reading your informative posts. Yes, I thought we should be able to combine all the companies on the FDA site and I will review that. I am printing this post to keep for future reference.

For now, we are remaining with FDA compliant labeling. We have the ability to print many customized labels and should the time come we have an interested EU party we will handle it at that time.
I don't know what I would do without the Cove!!
Medic
 
Elsmar Forum Sponsor
D

DevicesAU

#12
Re: Definition of "Legal Manufacturer"

Hi all,
At our company we have a discussion about the definition of legal manufacturer for the US. According to our consultant the legal manufacturer is always the company that produces the device and since we have contracted out the design, development, manufacturing to another company. We can not be the legal manufacturer since the contract manufacturer will be owner of the Design File and also of the 510K.
What is your opinion about this?
 
M

MIREGMGR

#13
Re: Definition of "Legal Manufacturer"

According to our consultant the legal manufacturer is always the company that produces the device
Maybe there's a mis-communication between your consultant and you. There's ample clarity in both USA and EU regulations and guidances that the actual maker may be responsible for the device, or may be a Contract Manufacturer (US FDA term) and not responsible for the device, with another party (such as the Specification Provider, US FDA term) being responsible for the device.

I don't know the particulars of your situation, of course. Perhaps you are the Specification Provider (and therefore the Responsible Manufacturer, even though you don't physically make the device) and the maker is a Contract Manufacturer. Another way to structure the relationship, of course, would be for the maker of the device to be the Responsible Manufacturer, and for you to be just a distributor.

(...)the contract manufacturer will be owner of the Design File
The Responsible Manufacturer (whichever party that may be) will be legally responsible for the content and maintenance of the DMR, DHF and DHR (US FDA terms), whether they physically maintain those documents themselves or contract out that document maintenance, for instance to the Contract Manufacturer.

A Contract Manufacturer, per US FDA definition, cannot be legally responsible for the DMR/DHF since those responsibilities inherently attach to the Responsible Manufacturer; and can have no more than co-responsibility for the DHR.

(...) and also of the 510K.
Ownership of a 510(k) by other than the Responsible Manufacturer is always a can of worms. I've never understood why FDA hasn't comprehensively clarified this issue at some point.

By precedent, ownership of a 510(k) does not define device responsibility, unless the owner of the 510(k) has allowed someone else to reference that 510(k) for a particular device and FDA determines that the "someone else" is not suitable as a Responsible Manufacturer. As noted in prior posts in this thread, every device must have one Responsible Manufacturer. If there's a 510(k) involved, and no one else is properly handling responsibility, FDA could decide that the 510(k) owner is who they'll go after.
 
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