FDA Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
Title:
FDA Guidance for FDA
Reviewers
Premarket Notification
Submissions for Empty
Containers for the Collection
and Processing of Blood and
Blood Components
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062943.pdf
Document Type:
Guidance for FDA Reviewers
Content:
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.