FDA WARNING_LETTER - LifeCell Corporation

The FDA issued a Warning Letter to LifeCell Corporation concerning its Strattice Reconstructive Tissue Matrix, which the agency determined is being marketed without proper clearance or approval. The device is deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. Furthermore, the device is misbranded under section 502(o) of the Act and 21 CFR 807.81(a)(3)(ii) due to major changes in its intended use without a new premarket notification (510(k)) submission. Specifically, while cleared for general soft tissue reinforcement, the firm's promotional materials indicate its use in breast reconstructive surgery, which constitutes an unapproved major change. LifeCell Corporation is required to immediately cease activities leading to the misbranding or adulteration of the device and promptly correct all violations. The firm must notify the FDA in writing within fifteen business days, detailing corrective actions, prevention plans, and a timetable for completion. Failure to comply may result in regulatory actions including seizure, injunction, or civil money penalties, and may impact federal contract awards.