Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world and I have a question regarding device registration. For Class I and Class II private labels devices, do they need to be registered in the FURLS site? The original brand/labels are registered and have been approved through the Pre-Market approval process but I am not sure if the private labels would still need to be registered as well.

I hope someone can answer me. Thank you!

Yes, this is mentioned in the device listing FAQs.


https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements#brand


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Anne LeBlanc
United States
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Original Message:
Sent: 16-Aug-2022 11:08
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world and I have a question regarding device registration. For Class I and Class II private labels devices, do they need to be registered in the FURLS site? The original brand/labels are registered and have been approved through the Pre-Market approval process but I am not sure if the private labels would still need to be registered as well.

I hope someone can answer me. Thank you!