Premarket Notification Submissions for Blood and Plasma Warmers Guidance for FDA Reviewers July 2001

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0484
• Issued by: Center for Biologics Evaluation and Research

This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for blood and plasma warmers used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.
 

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