Use of Sterile Connecting Devices in Blood Bank Practices Guidance for Industry November 2000

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0486
• Issued by: Center for Biologics Evaluation and Research

Sterile connecting devices produce sterile welds between two pieces of compatible tubing. This procedure permits sterile connection of a variety of containers and tube diameters. This guidance describes recommended practices and procedures for use of these devices. This guidance does not address the data or information that a manufacturer of a sterile connecting device must submit to FDA in order to obtain approval or clearance for marketing. It is also important to note that the use of an approved or cleared sterile connecting device for purposes not authorized in the labeling may cause the device to be considered adulterated and misbranded under the Federal Food, Drug and Cosmetic Act.

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