Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, your product is intended for use in the treatment of certain conditions involving the musculoskeletal system and promoting a healing response, treatment of inflammation and wound healing as well as use in treatment of soft tissue voids, and soft tissue augmentation during repair of surgical defects.
Passage 2your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.10(a)
- 21 CFR 1271.15
- 21 CFR 1271.3(d)
- 21 CFR 1271.3(c)
- 21 CFR 1271.2
- 21 CFR 312