LifeCell biomaterial/skin/wound news

LIFC received a letter from the FDA's Center for Devices and Radiological Health (CDRH) stating that some divisions within the agency continue to advocate regulation of the company's AlloDerm universal tissue grafts as a device. However, the letter also stated that the FDA is still developing its policies involving human tissue products and suggested LIFC contact the Ombudsman's Office to discuss the jurisdictional issues.

In November, CDRH notified LIFC that the agency considers the product a device (see BioCentury Nov. 20). At the time, LIFC responded that AlloDerm should be regulated under existing regulations covering human tissue for transplantation. ...