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

Hi Ya'll!

Quick question - For a US company private labeling a FDA class II device - isn't it required that this OEM company obtain a 510(k) for their private labelled product even if the source manufacturer possesses 510(k) clearance for the same device with different labeling? What is your take on this?

Senna

The 510(k) is not required if the device is being distributed under a "Private Label", i.e., a preamendment device or device with a valid 510(k) which is being placed into commercial distribution for the first time by a distributor under their own name or a repackager who places their own name on a device provided no changes are made to the device or its indications for use, and it is not further processed, e.g.. sterilized.

See:
PREMARKET NOTIFICATION 510(k):REGULATORY REQUIREMENTS FOR MEDICAL DEVICES

Re: FDA 510(k) required? US company private labeling a FDA class II device

senna said:

Hi Ya'll!

Quick question - For a US company private labeling a FDA class II device - isn't it required that this OEM company obtain a 510(k) for their private labelled product even if the source manufacturer possesses 510(k) clearance for the same device with different labeling? What is your take on this?

Senna

Click to expand...

Hi Senna,

There are very few Class II devices that would require concurrence on a 510(K) to transfer production to an OEM. Generally, as long as the OEM's labeling doesn't change the general intended use of the device, or its claims, it will not need to apply for clearance. The company that contracts the OEM will be expected to manage it through its purchasing controls processes.

FDA doesn't approve labeling for 510(K) devices. So, the labeling that's included in the submission generally consists of the basic elements: brand name, claims, warnings, etc.

The person responsible for regulatory affairs at the company that owns the cleared device should be monitoring and approving the labeling that the OEM ultimately places on the product. The responsibility for the safety and effectiveness of the device will remain on the owner - not the contractor. So, the 510(K) owner will need to perform the necessary supplier qualification (ie supplier audit) and transfer of production, including process validation, in order to consider the OEM "qualified".

What kind of device is it?

Chris Ford

Re: FDA 510(k) required? US company private labeling a FDA class II device

Is the company that is buying products and private labeling required to put the manufacturers name on the label under Manufactured by and their name under Distributed by?

Re: FDA 510(k) required? US company private labeling a FDA class II device

melvin345 said:

Is the company that is buying products and private labeling required to put the manufacturers name on the label under Manufactured by and their name under Distributed by?

Click to expand...

Are the products being bought from a (US) registered device maker with appropriate regulatory clearances? If so, then they're the Manufacturer (unless the contract specified otherwise), and the labeling (in the US) should state either Manufactured For or Distributed By.

There is no US requirement for Manufactured By. That message (in symbol form) is used on EC compliant labels, though.

Note that (in the US) if you are applying labels as a Distributor, you may need to be registered as a Re-Labeler, and you may (under certain circumstances) need contractural permission from the Manufacturer.

Re: FDA 510(k) required? US company private labeling a FDA class II device

Yes the products are manufactured in US and are registered in US and EU and have a 510k. We are actually the manufacturer and a company is buying our products in bulk and labeling themunder their name and I want to make sure they are in compliance with regulations.

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.

Al Rosen said:

The 510(k) is not required if the device is being distributed under a "Private Label", i.e., a preamendment device or device with a valid 510(k) which is being placed into commercial distribution for the first time by a distributor under their own name or a repackager who places their own name on a device provided no changes are made to the device or its indications for use, and it is not further processed, e.g.. sterilized.

See:
PREMARKET NOTIFICATION 510(k):REGULATORY REQUIREMENTS FOR MEDICAL DEVICES Dead Link removed.

Click to expand...

I have a situation, and I am not sure if we can consider the device is being distributed under a Private Label.

Our software medical device has received 510(k) clearance. Instead of selling the product ourselves, the company has decided to partner with the big players in the industry and let them to sell the software product under their names. Doing so, the software product will need to make some modifications in company logo, product name, authentication, etc, but fundamentally, it is our product and nothing serious to affect the Indications for Use.

Here are my questions:

1) Can we consider the device is being distributed under a Private Label?

2) Do the big players need to submit 510 (k)?

3) If not, does this consider "another device being introduced into commercial distribution" under the Listing and Registration regulation? Do we need to list them as our product?

4) What if the big players do not agree with we list the product and insist they are the party to list the product? Do they need to file a 510 (k)?

I would really appreciate any help.

sueliu said:

I have a situation, and I am not sure if we can consider the device is being distributed under a Private Label.

Our software medical device has received 510(k) clearance. Instead of selling the product ourselves, the company has decided to partner with the big players in the industry and let them to sell the software product under their names. Doing so, the software product will need to make some modifications in company logo, product name, authentication, etc, but fundamentally, it is our product and nothing serious to affect the Indications for Use.

Here are my questions:

1) Can we consider the device is being distributed under a Private Label?

2) Do the big players need to submit 510 (k)?

3) If not, does this consider "another device being introduced into commercial distribution" under the Listing and Registration regulation? Do we need to list them as our product?

4) What if the big players do not agree with we list the product and insist they are the party to list the product? Do they need to file a 510 (k)?

I would really appreciate any help.

Click to expand...

I don't see any answers to this question, and the company I work for in a similar situation. Can you share with me your conclusions? We also have a software device that is being rebranded by much larger partner. The software is slightly different, but the indications are the same.

Our current line of thinking is as follows, not sure if it is correct.
1) the big partner will use the relabeling /repackaging strategy to avoid to submit a 510 (k).
2) We will not list the partner's product with FDA, since the partner's product is essentially the same as our product. The partner will list the customized product with FDA.
3) the big partner will be the manufacturer for the product in label, and will be the responsible party for the after market surveillance.
Hope this helps.