FDA WARNING_LETTER - Alveologic LLC

The FDA issued a Warning Letter to Alveologic, LLC for marketing the Propel System device without required clearance or approval. On February 6, 2013, the FDA's Office of Compliance reviewed Alveologic's website, which claimed the Propel System, through "Alveocentesis," stimulates alveolar bone to reduce orthodontic treatment time by 60% or more.

The FDA determined the Propel System is a device under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The device is adulterated under section 501(f)(1)(B) of the Act because Alveologic lacks an approved premarket approval (PMA) application or an approved investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act.

The FDA requested Alveologic immediately cease marketing the Propel System for unapproved uses. The firm must take prompt action to correct these violations. Failure to do so may result in regulatory actions including seizure, injunction, civil money penalties, and federal agencies being advised when considering contract awards. Alveologic must respond in writing within fifteen business days, detailing specific corrective steps, prevention plans, and documentation, including a timetable if corrections extend beyond