LST (Device Listing Number) for Medical Device Contract Manufacturer

[gunilletta]

Hi everyone,
I'm meeting a problem in exporting in the US a medical device class I. The FDA is holding the container because our LST number is apparently incorrect.
Unfortunately, I don't know where and how I can get the right LST number. Should this number have been supplied by FDA along with our FDA registration as a factory ? By the way,we are contract manufacturers. As you understand, it's not me who made all the registration at the FDA at the very beginning.

Thanks in advance for helping!
Gunilletta

[MIREGMGR]

In Reply to Parent Post by gunilletta

(...) we are contract manufacturers

As a maker located outside USA and shipping to USA, you probably fit within the FDA definition of a "Foreign Establishment" that is a "Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer." See http://www.fda.gov/MedicalDevices/De...ctmanufacturer

As such, you are required not just to Register, but also to List your products. This Listing is independent of the Listing that is maintained by the USA specification provider and marketer.

Probably the FDA District Office with which you are dealing wants your Listing number for the product in question.

[Marc]

For those of us following along:

LST = ?

[Stijloor]

Device Listing Number.

Re: Page 2 in this document.

Stijloor.

[Marc]

Thanks. It helps with Tags and thread titles, too.

FDA - ACS INTERFACE AFFIRMATION OF COMPLIANCE CODES attached.

[MIREGMGR]

In Reply to Parent Post by gunilletta

As you understand, it's not me who made all the registration at the FDA at the very beginning.

Another point: note that Registration must be renewed annually, and Listings must be stated to have been verified at that time. And, you cannot be Registered without having at least one active Listing.

So, if you aren't familiar with what's in your Listings and you have general regulatory responsibility, you might want to check to see whether your Registration in fact is still in effect.

This is the public database window, good for quick checks:

(Note however that this static view is only updated once a week, usually on Sunday, from the actual working database where new entries are created and edits are done.)

http://www.accessdata.fda.gov/script...cs/cfRL/rl.cfm

If you need to modify your registration or listing status, you'd use the secure FURLS / DRLM site:

https://www.access.fda.gov/oaa/