New Life Medical Services, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. §355(a). Your products are also unlicensed biological products in violation of section351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).

Passage 2

your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body.

Passage 3

your Restor+, Regain, and Renyte products fail to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because the processing alters the original relevant characteristics of the umbilical cord tissue related to its utility for reconstruction, repair, or replacement.

Passage 4

your Restor+, Regain, and Renyte products fail to meet the criterion that the HCT/Ps be "intended for homologous use only," which means that the "labeling, advertising, or other indications of the manufacturer's objective intent" demonstrate that the HCT/P is intended to perform "the same basic function or functions in the recipient as in the donor"

Passage 5

Your products are not the subject of an approved BLA.