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Hello,
My company is planning to produce cell-based products derived from blood and sell them for preclinical research use only (not for use in humans). In reviewing the FDA website for blood establishments, it states the following: "All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65." In review of the exemptions listed under 607.65, the most relevant to our situation would be: "
(c) Persons who manufacture blood products which are not for sale, rather, are solely for use in research, teaching, or analysis, including laboratory samples."
We are producing products strictly for research; however, they will be "for sale." Does this mean that we will need to register?
Additionally, we may be producing cell-based products derived from tissue, but would not be solely regulated under 21 CFR 1271. It does not appear that these products sold solely for preclinical research would require registration. Any insights as to why cell-based products derived from tissue would be handled differently from blood?
Does anyone have experience registering solely for research use only products? Thank you in advance for your input!