FDA WARNING_LETTER - LifeNet Health

The FDA issued a Warning Letter to LifeNet Health regarding their MatrACELL? Pulmonary Artery Patch Allograft. The letter, referencing CMS #128430, states that LifeNet Health is marketing the device for a new intended use without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The FDA reviewed LifeNet Health's website on July 14, 2010, and found promotional claims for the MatrACELL? Allograft, specifically "reduced immune response." While the device's premarket notification (510(k)), K081438, was cleared for repair of the right ventricular outflow tract, it was not cleared for the "reduced immune response" claim. This claim constitutes a major change in intended use, requiring a new premarket notification per 21 CFR 807.81(a)(3)(ii).

Consequently, the MatrACELL? Allograft is deemed adulterated under section 501(f)(1)(B) of the Act because there is no approved PMA or IDE. It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device for the new intended use, as required by sections 510(k) and 21 CFR 807.81(a)(3)(ii).

The FDA demands LifeNet