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Re: Company Develops Specifications - Manufacturing is Outsourced - Registration Ques
Melissa,
FDA lumps all specification developers, specification providers, contract manufacturers, etc into the "manufacturer" category, and you are responsible for maintaining a QMS and complying with 21 CFR 803, 806, 820, and the general regulations for anything having to do with FDA.
Per FDA 21 CFR 820 general definitions:
"(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."
It's frustrating, but you'll get through it!
Melissa,
FDA lumps all specification developers, specification providers, contract manufacturers, etc into the "manufacturer" category, and you are responsible for maintaining a QMS and complying with 21 CFR 803, 806, 820, and the general regulations for anything having to do with FDA.
Per FDA 21 CFR 820 general definitions:
"(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."
It's frustrating, but you'll get through it!