Finding Medical Device Listing Numbers on the USA's FDA site

E

Exact

#1
Can anyone tell me where to find a specific Medical Device Listing Number on the FDA site? I can find all of the classifications and reulations, but am unable to look up or find a specific device listing number. Thanks.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Finding Medical Device Listing Numbers on the FDA site

The FDA has two device databases: a public one that's accessible via their website and includes a table of listed products but not the listing information itself or listing numbers, and a secured one that contains that listing information and numbers, and is where that information is entered and may be edited.

Listing numbers are not publically available from the FDA.
 
M

MIREGMGR

#4
Re: Finding Medical Device Listing Numbers on the FDA site

That works for tracking down the K or Approval number. I think the specific request above was for the Listing number, which would be the D or E number in the DRLM database. We get those requests occasionally...I think there's a Department of Commerce form somewhere that requires D/E numbers, even though no one knows them but the Manufacturer.
 

yana prus

Involved In Discussions
#6
Re: Finding Medical Device Listing Numbers on the FDA site

MIREGMGR, I agree with you regarding the listing number form and it's location. Recently I'm getting more and more such requests from USA customs. Listing number is assigned by CDRH during the initial listing of the device in the DRLM website. There might be a few listing numbers for the medical device system system - one for the main component, and some for the other components and accessories.
In the recent letter to the industry about import entry review process from March 24, 2011,
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm248321.htm
it clearly states that listing number is the type of information that must be provided/transmitted electronically to the United States Customs and Border Protection (CBP) when an imported product arrives in the US. Therefore foreign manufacturers should be familiar with their listing numbers and need to mention it on the Affirmation of Compliance Statement for the products they export to USA.
 
M

MIREGMGR

#7
Re: Finding Medical Device Listing Numbers on the FDA site

Yes, since my earlier post the FDA has introduced the PREDICT import-information system. In many cases, FDA border offices want screenshots of DRLM listing pages...not just the textual information...with the PREDICT filing.

That essentially makes it impossible to import medical devices into the US using older information that the importer might have on file, without the regulatorily responsible Manufacturer's current participation.

I've made one or two other posts here recently with more specific information on how PREDICT actually works, based on our interactions with FDA Maryland, FDA Dallas and the El Paso border office, and several large kit packers.
 
B

baseball2k2k

#9
Re: Finding Medical Device Listing Numbers on the FDA site

In regards to PREDICT, does this have any relation to ACE?
 

somashekar

Staff member
Super Moderator
#10
Re: Finding Medical Device Listing Numbers on the FDA site

I am tasked with updating our contract manufacture status in our device listing on the FURLS site. I have all the information like the 510k number, the product code, Device name and the proprietary name from my principle. However I cannot go ahead without the Listing number (the D number) ...
NOW:
1. While I am asking my principle to provide the Listing number to me, however is there any way I can get this listing number from the FURLS, with the above known information ?
2. Should the device name that I update have the Principle's name along with the model number ?
 
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