Changes to existing Medical Device marketed under different name

LievenDW

Involved In Discussions
#1
Dear 510(k) experts, we have a device of which we have a 510(k). We make some changes to the device, and according to the flowchart about deciding when to submit a new 510(k), we conclude the applied changes don't require a new 510(k). Documenting the changes would be sufficient. BUT, the updated device is going to be marketed under a different name than the one mentioned on the original 510(k). Does that change the conclusion of whether or not to do a new filing?
 
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Stijloor

Staff member
Super Moderator
#2
Dear 510(k) experts, we have a device of which we have a 510(k). We make some changes to the device, and according to the flowchart about deciding when to submit a new 510(k), we conclude the applied changes don't require a new 510(k). Documenting the changes would be sufficient. BUT, the updated device is going to be marketed under a different name than the one mentioned on the original 510(k). Does that change the conclusion of whether or not to do a new filing?
Can someone help Lieven?

Thank you!!

Stijloor.
 

LievenDW

Involved In Discussions
#4
Not really, Gert, but thanks for the link anyway. I've searched the FDA website on this topic but could not find an answer. I can only guess that a change of device name is considered a change in labeling, and should be taken into account as such in the decision flow.
 
G

Gert Sorensen

#5
I believe it may fall under the "Letter to file" issue. Just to inform them that the trade name has been changed.
 
M

mknight

#6
You change the marketed name under the FDA device listing, thus linking the old 510k to the devices new name. Most folks change/update their device listings during the annual establishment registrations but I believe you are supposed to do it within 30 days of marketing the new name.

:)
 
K

Katalina

#7
I believe you can just update the Proprietary Names section of the device listing associated with that 510(k) number, or add the new and leave the old. Many 510(k) are submitted with the name assumed at that time, and then Marketing decides to change it before launch. Per the Procedures section of the Guidance document K97-1, "In effect, manufacturers need to submit a new 510(k) only when a change, or the sum of the incremental changes exceeds the §807.81(a)(3) threshold, "could significantly affect the safety or effectiveness of the device."
 
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