Rule CG-TRC-001
Regulatory status: what rule CG-TRC-001 checks
Rule CG-TRC-001 is one of the checker's regulatory status rules. It cites 21 CFR 807.39. The reason, source and safer wording are below.
CG-TRC-001 · Warns · Citation checked against stored text
FDA registration, certification, inspection or exemption does not mean a product is approved, safe or effective, and approval claims for stem cell, exosome, pellet, compounded or device products are usually false.
Source: FDCA section 301 and 21 CFR 807.39 (registration does not denote approval); FTC Act section 5 deception; FDA guidance on regenerative medicine and compounding
Safer wording: Do not use FDA registered, certified or exempt as a quality claim. Say exactly what FDA has cleared or approved, for which use, or say nothing about FDA.
21 CFR 807.39 · Needs counsel review
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