Establishment Register Question - Subcontracting - Blood Glucose Monitor System

L

Laura Halper

#11
Hi Shawn,
For some reason, I'm not able to attach the link to this message, but go back to Ajit Basrur's earlier reply and click onto "Who Must Register, List and Pay the Fee". This is a page on the FDA's website that has a table listing various persons and whether or not they must Register, List, and pay the (registration) fee. You'll see both Contract Manufacturer Who Commercially Distributes the Device, and Contract Manufacturer Who Does NOT Commercially Distribute the Device, with different requirements.

My interpretation of the regs is that yes, even if the contract manufacturer distributes only to foreign countries, they would still be required to register and list with the FDA. This is because the FDA has jurisdiction over companies involved in interstate commerce, and the Food Drug and Cosmetic Act, Section 201(b), defines interstate commerce as "commerce between any State or Territory and any place outside thereof..." So interstate commerce is not limited to areas within the U.S.

You could query the FDA on this point in order to get definitive answer, and maybe get a specific reference that you could give to your contract manufacturers who don't believe that they need to register/list.

If you do decide to ask the FDA, please let the forum know what they say. This will help educate me for sure! and maybe some other folks as well.

Regards,
Laura
 
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