Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair or Reconstruction; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair or Reconstruction.'' The guidance was prepared by the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Devices and Radiological Health. The document is intended to provide guidance on FDA's approach to the regulation of living autologous cells manipulated ex vivo and intended for structural repair or reconstruction (Manipulated Autologous cells or MAS cells). The agency is also inviting comments on the guidance.