Medical Device Registration of Multiple Sites

T

Totumfrog

#1
Good afternoon all. Due to the changes in definition from the FDA, our company is now required to register as a contract manufacturer. Here is the problem. We are a corporation made up of multiple design and manufacturing sites. One site is already registered and has been for a while. However it is listed under it's old name before the corporation purchased it. It appears that I need to update the name of the existing site and register the additional site (separate states). However it wasn't clear on the FDA website if I need to pay the user fee for both sites and get separate FDA numbers or if we pay the user fee for the original listing site only and then register the second site as an additional location. It is compounded by the fact that we have the same Federal Employee Identification Number so the website instantly takes me to the original site and only allows me to pay the user fee for the original site. Does anyone else have multiple sites registered and if so do you pay separate fees for each and have separate numbers for each or one fee / one number? Thank you.
 
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M

MIREGMGR

#2
The rules are fuzzy regarding when multiple facilities must be handled as multiple Establishments, except in one respect: each facility that is responsible for creation of a finished device must be an Establishment.

If you have multiple facilities but all of your finished devices are manufactured at just one of those facilities, probably you can Register as a single Establishment.

The "fuzziness" has to do with how much involvement in a product-process constitutes responsibility for it.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
The rules are fuzzy regarding when multiple facilities must be handled as multiple Establishments, except in one respect: each facility that is responsible for creation of a finished device must be an Establishment.

If you have multiple facilities but all of your finished devices are manufactured at just one of those facilities, probably you can Register as a single Establishment.

The "fuzziness" has to do with how much involvement in a product-process constitutes responsibility for it.
I understand that "A Contract Manufacturer" manufactures finished medical devices. Otherwise they are component makers. Hence, if a site doesn't ship finished medical devices, it can't be considered a Contract Manufacturing establishment, can it?
 
G

Gert Sorensen

#4
I understand that "A Contract Manufacturer" manufactures finished medical devices. Otherwise they are component makers. Hence, if a site doesn't ship finished medical devices, it can't be considered a Contract Manufacturing establishment, can it?
That makes sense to me. I would think that they would be considered suppliers.
 
M

MIREGMGR

#6
I understand that "A Contract Manufacturer" manufactures finished medical devices. Otherwise they are component makers. Hence, if a site doesn't ship finished medical devices, it can't be considered a Contract Manufacturing establishment, can it?
Right, except if the site provides certain critical services, particularly sterilization. Sterilization contractors are contract manufacturers even if the devices they sterilize are not yet finally labeled and therefore may not yet be "finished devices", or if the sterilization contractor is working for a contract manufacturer and therefore is Tier 2.

The alternate condition is "component maker". The defining regulation is at 21CFR 807.65(a).
 
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