Memorandum on the Use of an FDA Cleared or Approved Sterile Connecting Device in Blood Bank Practice; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a memorandum dated August 5, 1994, to all registered blood establishments. In the August 5, 1994, memorandum, the Center for Biologics Evaluation and Research (CBER) recommends practices and procedures in the use of sterile connecting devices (STCD's). CBER also advises that certain uses of these devices may create a new product or significantly modify a regulated product, such that approval of a license application or an application supplement is required. This memorandum provides information to registered blood establishments on the use of STCD's.