I have been working with our contract manufacturer to get their device listing updated for the FDA so that we can import.

They provided me a copy of the completed listing and filing from the FDA and the listing number has a "D" prefix. Our listing number also has a "D" prefix. The contractor manufacturers and lists other products with the FDA but they all have "E" prefixes.

What do the different prefixes mean?

TIA!

I have been working with our contract manufacturer to get their device listing updated for the FDA so that we can import.

They provided me a copy of the completed listing and filing from the FDA and the listing number has a "D" prefix. Our listing number also has a "D" prefix. The contractor manufacturers and lists other products with the FDA but they all have "E" prefixes.

What do the different prefixes mean?

TIA!

http://www.fda.gov/cdrh/registration/foreignestablishments.html

Hi mlabardi,

I searched the FDA's web site and did not see a definition for "D" and "E" prefixes, however, here is a link that you might be able to do a more thorough search and maybe find something applicable.

Sorry I couldn't be of more help. :(

I have been working with our contract manufacturer to get their device listing updated for the FDA so that we can import.

They provided me a copy of the completed listing and filing from the FDA and the listing number has a "D" prefix. Our listing number also has a "D" prefix. The contractor manufacturers and lists other products with the FDA but they all have "E" prefixes.

What do the different prefixes mean?

TIA!

I am not sure if you are referring to 21 CFR Part 807.21 -
Times for establishment registration and device listing (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.21)

An owner or operator of an establishment who has not previously entered into an operation defined in 807.20 shall register within 30 days after entering into such an operation and submit device listing information at that time. An owner or operator of an establishment shall update its registration information annually within 30 days after receiving registration forms from FDA. FDA will mail form FDA-2891a to the owners or operators of registered establishments according to a schedule based on the first letter of the name of the owner or operator. The schedule is as follows:

First letter of owner or operator name Date FDA will mail forms
A, B, C, D, E March.
F, G, H, I, J, K, L, M June.
N, O, P, Q, R August.
S, T, U, V, W, X, Y, Z November.

(b) Owners or operators of all registered establishments shall update their device listing information every June and December or, at their discretion, at the time the change occurs.

For those of you who may have been wondering the answer...

I finally just asked the FDA. I was told that the letter pre-fixes don't actually mean anything and that the computer just generates a number since everything is now electronic.

Since the newer products have a "D" and the older products have an "E" its because the older ones were done prior to the electronic registration. They don't have any impact on anything.