Xenotransplantation--federal regulatory considerations.

Xenotransplantation may offer benefits to individual patients, but may also pose significant risks, to the recipient and to the public at large. The United States Food and Drug Administration endeavors to meet the challenge of regulating xenotransplantation to allow its development while safeguarding the public health. The approach includes using the existing FDA regulatory framework, publishing xenotransplantation-specific guidance documents, obtaining public input, and collaborating with other public health agencies and international bodies in order to develop and maintain a safe and rational program for the regulation of xenotransplantation.