Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components: Guidance for FDA Reviewers

Issue Date: July 19, 2001
Issued by: Center for Biologics Evaluation and Research
Topic(s): Application & Approvals, Blood Products
Status: Final

Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components: Guidance for FDA Reviewers

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

Download the Guidance Document