LifeCell Corp. makes announcement.THE WOODLANDS, Texas--(BUSINESS WIRE)--Nov. 17, 1995--LifeCell Corporation announced that it has received an inquiry from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) regarding the Company's labeling and the classification of AlloDerm universal tissue graft. The inquiry was in the form of a letter from the FDA's Dental ENT ENT ears, nose, and throat (otorhinolaryngology). ENT abbr. ear, nose, and throat ENT ear, nose and throat. ENT Ears, nose & throat; formally, otorhinolaryngology and Ophthalmic Devices Compliance Branch, Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. (CDRH) stating that, based upon receipt of certain product labeling, they consider the product to be a "device" as defined under the Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. . This inquiry follows the Company's recent commercial introduction of AlloDerm tissue for periodontal applications. The Company has filed a response with the CDRH stating that AlloDerm processed allograft allograft: see transplantation, medical. dermis dermis: see skin. is currently regulated as a banked human tissue under 21 Code of Federal Regulations The New Deal program of legislation enacted during the administration of President franklin roosevelt established a large number of new federal agencies, which generated a shapeless and confusing mass of new regulations. , Part 1270, entitled Human Tissue for Transplantation. LifeCell has marketed AlloDerm tissue for over two years as a skin graft for third-degree burns and has not received any previous notification from the FDA regarding possible reclassification Reclassification The process of changing the class of mutual funds once certain requirements have been met. These requirements are generally placed on load mutual funds. Reclassification is not considered to be a taxable event. of human skin tissue as a medical device. "We are cooperating fully with the FDA to expeditiously clarify the appropriate labeling and classification of AlloDerm processed human tissue," stated Paul M. Frison, LifeCell's president and chief executive officer. "We expect that this issue will be resolved without any effect on our operations." AlloDerm universal tissue grafts are processed from donated cadaveric (human) skin. The grafts consist of a preserved dermal tissue matrix from which cells that stimulate immune rejection are removed. Transplanted AlloDerm tissue engrafts and becomes repopulated with the recipient patient's own cells. AlloDerm tissue grafts are used clinically to augment skin grafting of third-degree burn patients, reducing the thickness of skin required from the patient's own body, and in periodontal (gum) grafting procedures. LifeCell Corporation is an industry leader in the development and commercialization of universal tissue grafts and blood preservation products. In addition to AlloDerm tissue grafts, the Company's current universal tissue graft development programs include heart valves and vascular conduits. LifeCell's product development programs also include ThromboSol, a formulation for extending the shelf-life of transfusable platelets. CONTACT: LifeCell Corp., The Woodlands Jane Lea Hicks, 713/367-5368 |
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