LifeCell regulatory update

The FDA's Center for Devices and Radiological Health (CDRH) notified LIFC that the agency considers the company's AlloDerm universal tissue graft a "device" under the Federal Food, Drug, and Cosmetic Act.

LIFC, which has marketed AlloDerm for more than two years as a skin graft for third-degree burns, said the agency's interest in the product's label follows the commercial introduction of the processed cadaver skin for periodontal applications. ...