AngioDynamics, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Angiodynamics, Inc. regarding their NanoKnife/Oncobionic System. The FDA determined the firm is marketing the device in the U.S. without required marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.

Angiodynamics had obtained 510(k) clearances for the Oncobionic System (K080376), Oncobionic System with 6 probe output (K080202), and Oncobionic Bipolar Electrode (K080287), all indicated "for surgical ablation of soft tissue." However, an FDA review of the firm's website on January 4, 2010, revealed promotional materials, including a brochure and instructions for use, that made claims and used terms like "treat," "treatment," and "therapy" to imply the device's use for specific diseases or conditions. These claims included treating patients with locally advanced, unresectable disease, treating lesions near critical structures without collateral damage, and suggesting minimal post-procedural pain.

These statements represent a major change in the device's intended use, requiring a new premarket notification (21 CFR 807.81(a)(3)(ii)). Consequently, the NanoKnife device is adulterated under section 501(f)(1)(B) of the Act for lacking an approved PMA or IDE, and misbranded