FDA WARNING_LETTER - Tesla Biohealing, Inc. - March 23, 2023

On August 10, 2023, the FDA issued a Warning Letter to Tesla BioHealing, Inc. following an inspection from March 20-23, 2023. The firm manufactures Tesla MedBed Generator and Tesla BioHealer medical devices, marketed with claims of activating cellular self-repair for conditions like terminal cancers, stroke paralysis, and Alzheimer's.

The devices are deemed adulterated under 21 U.S.C. § 351(f)(1)(B) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under 21 U.S.C. § 352(o) for being introduced into interstate commerce for uses different from legally marketed infrared lamps (21 CFR 890.5500) without a 510(k) premarket notification. The devices lack a heating element and are marketed for treating various chronic illnesses, as evidenced by their website, "Intended Use Chart," and product labels.

Furthermore, the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations include: 1. Failure to establish and maintain design validation procedures (21 CFR § 820.