Changing a Medical Device Product Name

W

wangyang

#1
Dear all:

For a medical device which already finished its design, production, if i want to change the name of the medical device, and i want to know how to achieve it under the QSR820 system?

What activities should i do?

Thank you very much.
 
Elsmar Forum Sponsor
D

Dudes

#2
Is your device already approved and on sale?

If so, I would say you'd have at least to inform all the regulatory authorities of the countries where it is approved (in some of them, you need to get approval before being allowed to sell under the new name)

Unfortunately, I don't know much about the specifics under QSR...
 
M

MIREGMGR

#3
The FDA expects to be informed of the intended marketing name of a device during the pre-market approval process, whether PMA or 510(k). The FDA exerts no control over marketing names for exempt devices.

Changes to the labeling of PMA devices may require submission of a new 510(k) (probably a Special), or may only require a memo to file. The "A" section of the FDA guidance at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm discusses the applicable rules at considerable length. A pure name change, with no intent or implications of effect to broaden intended use or extend or change the target market, may only require a memo to file.
 

Al Rosen

Staff member
Super Moderator
#4
A memo to file worked for me. I sent the FDA a letter with the information stating there were no changes to the device, intended use or labeling. They sent me a confirmation letter and I filed that as well.
 
A

arios

#5
I would inquire why the name is changing. Does it obey only marketing needs?
Is there a change on the intended use or intended users? Is the change coming along with change on precautions?
 

bio_subbu

Super Moderator
#6
My suggestion is, simply list the device with the new brand name under the K number issued. If you already marketed the device under the previous brand name, the Registration and Listing website allows the use of more than one proprietary name for the same K number.

Also, you need to send a Note to File to the Office of Device Evaluations stating the K number and that your company changed the device name from the one on the original submission to the new brand name.

Please be noted that don’t forget to include the K number of your device on the envelope and send it to below FDA address

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66 Room 0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

If the new brand name implies the claims or a use that was not cleared in the original 510(k) then you need to submit a new 510(k).

As MIREGMGR said, refer the labeling section of the FDA guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device. If you want to make any labeling changes keep details in your Design History File (DHF) and Device Master Record (DMR).
 

tehuff

Involved In Discussions
#7
If you send a Note to File to the Office of Device Evaluations notifying them of a device name change (with no change to indications, intended use, labeling,etc), will FDA send a new 510(k) clearance letter with the new device name listed on it?
 

Marcelo

Inactive Registered Visitor
#8
If you send a Note to File to the Office of Device Evaluations notifying them of a device name change (with no change to indications, intended use, labeling,etc), will FDA send a new 510(k) clearance letter with the new device name listed on it?
Nope.

Also, for a change of the name in a 510(k) process, you have to evaluate if the name change triggers a new 510(k) (most changes do not, but some may) - see Deciding When to Submit a 510(k) for a Change to an Existing Device.

You also need to change your device listing.
 
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