Vericel has submitted a humanitarian device exemption supplement to the FDA to revise the labeled indications of Epicel to specifically include use in pediatric patients.
Epicel (cultured epidermal autografts) is a permanent skin replacement for treatment of patients with burns comprising at least 30 percent of the body. It has been used in the U.S. and internationally to treat severely burned patients since 1988, and was approved in 2007 as a humanitarian use device.
HUDs are intended to treat or diagnose diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. A HUD is eligible to be sold for profit after receiving HDE approval if the device meets certain eligibility criteria, including treating a disease or condition that occurs in pediatric patients. — Jonathon Shacat