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GUIDANCE DOCUMENT

Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components Guidance for FDA Reviewers July 2001

Download the Final Guidance Document
Final
Docket Number:
FDA-2007-D-0251
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0251.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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