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FDA's DRLM (Device Registration & Listing Module) Listing Number Question - Page 2

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510(k), drlm (fda's device registration and listing module), fda (food and drug administration), listing number
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  Post Number #9  
Old 6th June 2018, 02:37 PM
JeantheBigone

 
 
Total Posts: 166
Re: FDA's DRLM (Device Registration & Listing Module) Listing Number Question

Registration and Listing shouldn't take very long.

How to Register and List

Step one is to get a DFUF account so you can pay the fee. Don't even look at the DRLM until you've paid it, because without both the Payment Identification Number and the payment Confirmation Number the system won't save anything you've entered. So you can spend an hour for nothing.

The fee goes by establishment address, so once you are registered, you can list as many devices as you want.

I'm not sure what you mean by LST#. If the foreign manufacturer or exporter isn't registered and hasn't listed, there is a much bigger problem. US Customs will spot check incoming goods and turn over inspection to an FDA Inspector. If that inspector cannot verify that the goods are coming from an establishment that is registered and has listed the device and is intended for an establishment that is registered and has listed the device (unless it's a final customer) then they will quarantine it and someone will get a detained entry notice.

It usually takes a day or two for payment to clear and once you have the PIN-PCN you can register and list.

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  Post Number #10  
Old 13th June 2018, 01:37 PM
jeinho1

 
 
Total Posts: 2
Re: FDA's DRLM (Device Registration & Listing Module) Listing Number Question

Thank You so much for your reply, JeantheBigone!
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