FDA WARNING_LETTER - Collagen Matrix Inc

On January 8, 2015, the FDA issued a Warning Letter to Collagen Matrix, Inc. regarding their Collagen Dental Wound Dressings. The FDA determined the firm was marketing these devices without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The Collagen Dental Wound Dressings are considered adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). They are also misbranded under section 502(o) because the firm introduced the devices into interstate commerce with major changes to their intended use without submitting a new premarket notification (510(k)).

Specifically, while the devices were cleared under K122115 for managing oral wounds, the firm's website promoted them for controlling minor bleeding, a hemostatic claim. The FDA had previously advised the firm to remove hemostatic claims during the K122115 review. A hemostatic claim requires an approved Class III device PMA under 21 CFR 878.4490.

Collagen Matrix, Inc. is required to immediately cease activities resulting in the misbranding or adulteration of the devices. The firm must provide a written response within fifteen business days detailing corrective actions, a plan to prevent recurrence, and a timetable for implementation if corrections will take longer. Failure to