Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods" dated January 2001. The guidance document provides recommendations to blood establishments for the use of FDA cleared automated blood cell separators for the collection of both single and double units of red blood cells. The guidance document also describes information to be included in a licensed application or supplement. The guidance document announced in this notice finalizes the draft guidance document entitled "Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods" dated July 1998.