Public Hearing: Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Implantation for Structural Repair or Reconstruction

Resumo

The Food and Drug Administration (FDA) is announcing a public hearing to discuss the regulation of products that are comprised of living autologous cells manipulated ex vivo and intended for implantation for structural repair or reconstruction of the source tissue or other tissue, including products used for cosmetic reconstruction and augmentation. The products to be discussed at this hearing are described in further detail in this document. In view of the emergence of new autologous cell products and the potential enhancement to the public health, the purpose of the hearing is to solicit information and views from interested persons, including scientists, clinical investigators, professional groups, trade groups, commercial enterprises, and consumers, on the issues and concerns relating to regulation of such products. Preregistration by written notice is advised to ensure participation. The procedures governing the hearing are found in 21 CFR part 15.