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Hi everyone!
We are a small start up company who has obtained and MDL in Canada and have devices in market in that country, but are not yet in market in the US. In reading through the FDA's website to determine whether or not to register our establishment and pay the Establishment Listing Fee, it's unclear to me if we need to register.
The FDA's web page "
Who Must Register, List and Pay the Fee" states that "U.S. Manufacturer of export only devices" must pay the fee according to 21CFR807.20(a)(2). When referencing 21CFR807.20(a)(2), it states the following:
(a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term "device" includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Service Act. An owner or operator of an establishment located in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall register its name, places of business, and all establishments and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce. The registration and listing requirements shall pertain to any person who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use, including any person who:
(2) Sterilizes or otherwise makes a device for or on behalf of a specifications developer or any other person
In this case could the "any other person" in line 2 considered another country, such as Canada? I'm failing to see how 21CFR807.20(a)(2) is applicable to "U.S. Manufacturer of export only devices".
Thank you in advance for any insight you may be able to offer!