Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components

September 15-16, 2009

Workshop Goals and Objectives

The Food and Drug Administration (FDA) held a public workshop entitled: FDA Regulation and Licensure of Whole Blood and Blood Components, including Source Plasma.  The purpose of the workshop was to educate industry on the licensure requirements and license application procedures for Whole Blood and blood components, including Source Plasma.

FDA held a licensing workshop for blood establishments in 1995 to advise the blood and plasma industry on how to apply for a U.S. license to distribute Whole Blood and blood components, including Source Plasma, in interstate commerce. This workshop built upon the 1995 workshop and provided regulatory updates since the last workshop. The workshop included presentations by FDA on the following topics: (1) requirements for licensure, and applicable regulations and guidance documents for Whole Blood and blood components, including Source Plasma; (2) managed review process; (3) review criteria for various submissions; (4) blood establishment registration and product listing requirements; (5) inspections of blood establishments pending licensure and approval; and (6) requests for exceptions or use of alternative procedures to the regulations. The workshop included general sessions as well as break-out sessions with a particular focus on Whole Blood and blood components or Source Plasma. A question and answer session with workshop participants was also included in the workshop.

Location

The Universities at Shady Grove Conference Center
9630 Gudelsky Drive
Rockville, MD 20850