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Device marketed by someone else & different name...is a 510(k) required?

P

potato124

#1
Hello! If an existing Class II device is marketed by another company and under a different brand name (and the label changes but not the IFU), but the OEM holds the 510(k) and does all of the manufacturing, does a new or Special 510(k) have to be submitted by the new distributor? Does any notice to the FDA have to be filed when the marketed name and company changes?
 
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I

icare2much

#2
First let me clarify - IFU = Instructions for Use?

Who is relabeling? The new company or the original manufacturer? At a minimum, if the new company is relabeling, they would be required to register - see the link below:

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm

I suspect they would need a 510(k) as well but perhaps a more experienced Cover could steer you in the right direction.

If the original manufacturer is relabeling and the new label still contains their identify as a manufacturer, then:

a) no 510(k) is needed; the model or brand change can be handled in a letter to file (for example, a labeling design change that updates the DHF and DMR)

b) the new distributer is simply a distributer and does not need to register or submit a 510(k)
 
P

potato124

#3
First let me clarify - IFU = Instructions for Use?

Who is relabeling? The new company or the original manufacturer? At a minimum, if the new company is relabeling, they would be required to register - see the link below:

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm

I suspect they would need a 510(k) as well but perhaps a more experienced Cover could steer you in the right direction.

If the original manufacturer is relabeling and the new label still contains their identify as a manufacturer, then:

a) no 510(k) is needed; the model or brand change can be handled in a letter to file (for example, a labeling design change that updates the DHF and DMR)

b) the new distributer is simply a distributer and does not need to register or submit a 510(k)


Good questions, let me clarify:

The OEM (who owns the 510(k)), is relabeling the outside of the device to change the brand name, and then shipping the finished sterile device to the distributor. The distributor's name is on there, as well as the OEM as the "manufactured by" address. The Instructions for Use (IFU) and the Indications for Use did not change.

The reason I am confused is because in the regs it says "“Under section 510(k) of the Act, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin.” According to this, since this is a new device for the distributor, they should submit to the FDA.

The situation here is clearly a manufacturer - distributor, and since the Indications for Use are not changing, it is ok for the manufacturer to change the label for the new brand name without submitting a new 510(k). However, what tells me that the distributor does not need to submit a 510(k)?
 
G

gar4guv

#4
I do not believe you as a distributor have to submit a new 510k. If the OEM is changing the name of the product, they would probably just have to update their device listing.

If your company is only adding their name and not doing relabeling activities (changing the content of the labeling from that supplied from the OEM for distribution under your own name), then you should be able to market the device without any further actions on your part.

This is from the 510k guidance doc on the FDA website

When a 510(k) is Not Required
The following are examples of when a 510(k) is not required.

3. You distribute another firm's domestically manufactured device. You may place a label on the device, "Distributed by ABC Firm" or "Manufactured for ABC Firm," (21 CFR 801.1) and sell it to end users without submission of a 510(k).

4. In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
 
P

potato124

#5
I do not believe you as a distributor have to submit a new 510k. If the OEM is changing the name of the product, they would probably just have to update their device listing.

If your company is only adding their name and not doing relabeling activities (changing the content of the labeling from that supplied from the OEM for distribution under your own name), then you should be able to market the device without any further actions on your part.

This is from the 510k guidance doc on the FDA website

When a 510(k) is Not Required
The following are examples of when a 510(k) is not required.

3. You distribute another firm's domestically manufactured device. You may place a label on the device, "Distributed by ABC Firm" or "Manufactured for ABC Firm," (21 CFR 801.1) and sell it to end users without submission of a 510(k).

4. In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.

Got it. So the distributor does not need to submit a 510(k), however I don't think the OEM updated their device listing.

Here is more detail:
-The OEM is selling "Device A" using their own sales force, and it is listed with the FDA
-They made some minor changes (not requiring a new 510(k) per the flowcharts), and labeled is for the distributor as "Device B", now it is sent to the distributor and sold by their sales force.

Who's responsibility is it to inform the FDA that "Device B" is on the market? Is it the manufacturer who owns the 510(k), or the distributor (who also sells many other devices)?
 
Last edited by a moderator:
G

gar4guv

#6
I'm pretty sure its the manufacturer's responsibility,

from the regs:

Sec. 807.20 Who must register and submit a device list?


a) ... The registration and listing requirements shall pertain to any person who:

(2) Manufactures for commercial distribution a device either for itself or for another person. However, a person who only manufactures devices according to another person's specifications, for commercial distribution by the person initiating specifications, is not required to list those devices.
 
M

MIREGMGR

#7
I concur with gar4guv's posts above.

By and large, manufacturers, not distributors, are responsible for FDA regulatory compliance.
 
M

medic61

#8
I just asked the FDA the same question and gar4guv repeated what I was told. At first we wanted to have our name on the device, labeling, box and everything until we found out we would need the 510k so we compromised, got an exclusive sales area with the supplier and just added a label "Distributed by" on the outside of the carton.
Medic
 
Q

quest

#9
This thread is very interesting and pertains to our current situation.

Company A manufactures a device for which they have 510(k) and sells it under their own proprietary name using their own sales force. Their device listing includes their proprietary name.

Company B, a distributor, contracts Company A to supply them with the same device, the only difference is the the product labeling which is specified by Company B and includes their proprietary name, and the phrase "distributed by Company B." It does not mention Company A.

Per 801.20(a)(2) is Company A required to update their device listing to include Company B proprietary/brand name?
 
C

celia4237

#10
Update Registration & Listing Information
All owners or operators can access FURLS at any time throughout the year to update changes to their registration and listing information as those changes occur. Examples of changes to listings include:
  • another device being introduced into commercial distribution,
  • a change to a previously listed device, such as where it is being manufactured,
  • a previously-listed device is removed from commercial distribution or commercial distribution is resumed.
How about the name of the device is changed, that is, the label is changed for the distributor, does it need update of listing information?
 
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