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Hello,
Although below table on the FDA website demonstrates who should register. BUT still have questions about the following specific situations.
Situation#1: Company A is out of USA. Company A makes the products under its own name (such as products are manufactured by A, and with A's address on labeling). Company A sells and exports these products to USA's importer C.
Question: who should register and what Activity (from FDA table) should be chosen?
Situation#2: Both Company A and B are out of USA. Company A makes the products (under Company A's name, such as products are manufactured by A, and with A's address on labeling) and sells to Company B. Company B sells and exports these products to USA's importer C.
Question: who should register and what Activity (from FDA table) should be chosen?
Situation#3: Both Company A and B are out of USA. Company A makes the products (under Company B's name, such as products are manufactured by B, and with B's address on labeling) and sells to Company B. Company B sells and exports these products to USA's importer C.
Question: who should register and what Activity (from FDA table) should be chosen?
FDA table
Foreign Establishments
Foreign ManufacturersYES
807.40(a)YES
807.40(a)YES
Foreign Exporter of devices located in a foreign countryYES
807.40 (a)YES
807.40 (a)NO
Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer or by any other firmYES
807.40(a)YES
807.40(a)YES
Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer or by any other firm.YES
807.40(a)YES
807.40(a)YES
Reprocessor of Single-use DeviceYES
807.20(a)YES
807.20(a)YES
Custom Device ManufacturersYES
807.20(a)(2)YES
807.20(a)(2)YES
Relabeler or RepackagerYES
807.20(a)(3)YES
807.20(a)(3)NO
Kit AssemblerYES
807.20(a)YES
807.20(a)YES
Device Being Investigated under IDENO
812.1 (a) NO
812.1(a),
807.40(c)NO
Specification Developer YESYESYESRemanufacturerYESYESNOManufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)NONOMaintains compliant files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)YESYESYES
Thanks
Although below table on the FDA website demonstrates who should register. BUT still have questions about the following specific situations.
Situation#1: Company A is out of USA. Company A makes the products under its own name (such as products are manufactured by A, and with A's address on labeling). Company A sells and exports these products to USA's importer C.
Question: who should register and what Activity (from FDA table) should be chosen?
Situation#2: Both Company A and B are out of USA. Company A makes the products (under Company A's name, such as products are manufactured by A, and with A's address on labeling) and sells to Company B. Company B sells and exports these products to USA's importer C.
Question: who should register and what Activity (from FDA table) should be chosen?
Situation#3: Both Company A and B are out of USA. Company A makes the products (under Company B's name, such as products are manufactured by B, and with B's address on labeling) and sells to Company B. Company B sells and exports these products to USA's importer C.
Question: who should register and what Activity (from FDA table) should be chosen?
FDA table
Foreign Establishments
Activity
Register
List
Pay FeeRegister
List
Foreign ManufacturersYES
807.40(a)YES
807.40(a)YES
Foreign Exporter of devices located in a foreign countryYES
807.40 (a)YES
807.40 (a)NO
Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer or by any other firmYES
807.40(a)YES
807.40(a)YES
Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer or by any other firm.YES
807.40(a)YES
807.40(a)YES
Reprocessor of Single-use DeviceYES
807.20(a)YES
807.20(a)YES
Custom Device ManufacturersYES
807.20(a)(2)YES
807.20(a)(2)YES
Relabeler or RepackagerYES
807.20(a)(3)YES
807.20(a)(3)NO
Kit AssemblerYES
807.20(a)YES
807.20(a)YES
Device Being Investigated under IDENO
812.1 (a) NO
812.1(a),
807.40(c)NO
Specification Developer YESYESYESRemanufacturerYESYESNOManufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)NONOMaintains compliant files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)YESYESYES
Thanks