Interesting Discussion FDA 510(k) required? US company Private Labeling an FDA Class II Device

D

drewsky1

#21
Thanks for posting this information. Can you lead me to where "US FDA changed the rules so that both Marketers and Contract Manufacturers" this is documented. Is it on the FDA website?

Thanks
 
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wrensch

Starting to get Involved
#23
Re: FDA 510(k) required? US company private labeling a FDA class II device

Whoever currently has the product Listed on the US FDA DRLM site is the Manufacturer. Usually that's the same company that currently holds the 510(k). If that's you, then you're both the actual maker, and (probably) the Manufacturer.

A company buying your product in bulk and relabeling it themselves may be a Re-Labeler and/or a Distributor, or possibly may become the Manufacturer depending on the content of the label they apply, whether their claims and instructions for use differ from yours, and whether they also conduct additional operations other than labeling and packaging. If they are a kit packer, then regulatorily they may instead be a Kit Assembler.
I have a similar situation with a twist. We partnered with a company in the EU in the development of a device under our brand and model. We own the 510k and listed the device with our company as the manufacturer and the company that makes it in Europe as the Contract Manufacturer. The label says Manufactured for "our company" but it has their company logo. We recently discovered that they have been selling one in the US under their own brand with a different model name without our permission and making the same claims. They have not listed the device with the FDA nor do they have 510k clearance. My questions are 1. Is this legal? 2. If not, what are our options for recourse? 3. Do we have any liability? Any advice is GREATLY appreciated.
 
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Ronen E

Problem Solver
Staff member
Moderator
#24
Re: FDA 510(k) required? US company private labeling a FDA class II device

I have a similar situation with a twist. We partnered with a company in the EU in the development of a device under our brand and model. We own the 510k and listed the device with our company as the manufacturer and the company that makes it in Europe as the Contract Manufacturer. The label says Manufactured for "our company" but it has their company logo. We recently discovered that they have been selling one in the US under their own brand with a different model name without our permission and making the same claims. They have not listed the device with the FDA nor do they have 510k clearance. My questions are 1. Is this legal? 2. If not, what are our options for recourse? 3. Do we have any liability? Any advice is GREATLY appreciated.
Not a legal practitioner so take what I say with a pinch of salt.

Answers to your questions:

1. I guess not.
2. Consult your lawyer.
3. You might. You probably need to issue them a cease and desist letter as a first line of defence. Talk to your lawyer.

I guess it's also a good time to review your initial contract with them, to find out what exactly are their obligations and liberties.
 
W

WilBryan

#25
I have a tangentally related question about a Class II device and Im hoping someone here is willing to share their wisdom :bigwave:

If a device has been approved by a company and in production long enough for the patent to expire. If a competitor wishes to enter the market using the same tools, techniques, processes, and materials, will the competitor have to complete a full 510K application for their version of the product or will an abbreviated 510K suffice?

Any help or insight on this would be greatly appreciated.

thanks
w.
 

Mark Meer

Trusted Information Resource
#26
Hi WilBryan,

Companies can request a copy of your 510(k) submission via a FOIA request, however items deemed confidential will be redacted.

We've requested several over the years, and the FDA appears to redact more and more as time goes on (older 510(k)s we've received has a lot more information).

Also, a summary of your 510(k) is available to anyone on the FDA website, so if you're interested in what information the public has access to immediately, you might want to search for you 510(k) on the FDA website, and download the summary...

They can use this information to use your device as a predicate, making the 510(k) easier to draft, however if it is a new device (i.e. a new company making their own version of an existing device) they will still need to do a full 510(k).

Cheers!
MM
 
W

WilBryan

#27
Thanks Mark. Im doing some research for my father-in-law and this isnt my normal wheelhouse.
I have been pouring over some related 510K submissions and approvals. So it appears that if a patent expires, another company can ride the approval of the initial trials, testing etc... if their process, materials etc... are all similar? Is that the determination that the 510K submission is intended to make and document?
 

Mark Meer

Trusted Information Resource
#28
The 510(k) should demonstrate that the device is substantially equivalent to the chosen predicate (and any differences justified).

So, somewhere in the submission, there will generally be a comparison table showing the various details (indications for use, operation, power-supply, technology, materials..etc. etc.) of the device and predicate side-by-side.

The more similarities (i.e. the more items that can be stated as "same" between the new device and predicate), the easier the process, as there are fewer differences to justify.

I presume you've looked at the FDA Guidance on this? That's a good starting point.

I also suggest requesting a copy of the predicate 510(k) under FOIA, as this can make comparison much easier...

Hope that helps somewhat...
MM
 

Ronen E

Problem Solver
Staff member
Moderator
#30
Just to clarify: Patents have nothing (legally) to do with 510(k)s, except that patent contents may assist in understanding the technology's details and maybe construct a similarity argument (remember that an actual product doesn't have to be identical to the patant's specification).

Another important point to understand is that it's not enough to just state in a 510(k) "same" - you must be able to support it with evidence.
 
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