How to find the Medical Device Listing Number (MDL Number) from the FDA website?

C

cathyzhang

can i find the MDL number on the FDA website?
In the FDA database, i can only find:
Classification Name
Product Code
Device Class
Regulation Number
of the product, but how to find the medical device listing number?Thanks!!
 
M

medicalbiz

Has anyone out there found a way to get the Medical Device Listing Numbers for importing USA made medical equipment back into the USA?
 

nvquality

Starting to get Involved
I believe you'd have to contact the manufacturer, per FDA "...medical device listing number(s) are not available publicly. Medical device listing numbers can only be released to the owner/operator contact person or official correspondent of a registered establishment."

I can't provide a link but the source PDF document on the FDA website is titled: "How to download listing information from the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM)"
 
M

medicalbiz

Thank you Ajit for your quick reply.
We are a Canadian company dealing in used surplus equipment and having a lot of trouble with the FDA when shipping USA manufactured equipment back into the USA. They are looking for the MDLN which the manufacturers do not wish to supply. Should we be registered with the FDA? Would that help with this situation? Have spoken with a few FDA agents and they have not mentioned anything.
Thank you in advance
Ray
 

Ronen E

Problem Solver
Moderator
I don’t think that you being registered with the FDA would make any difference.

I wouldn’t be too optimistic about it, but there’s a chance you might get listing numbers through a FOIA request (mind you, there’s a fee and it takes some time).

Questions relating to FOI requests may be addressed to the Division of the Freedom of Information Offices at (301) 796-3900.

I’d call them and ask whether listing numbers are releasable under FOIA.

Another slim option: have you considered a CDRH petition?

Further reading on the topic
 
Last edited:
M

medicalbiz

Thanks for your reply Ronen!
i don't think a petition from a Canadian company is going to go very far ... I will pursue the FOIA angle.
Will keep you posted of any results.
Cheers
Ray
 
Top Bottom