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FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)

Internet:

https://www.gmp-compliance.org/files/guidemgr/pmatransfer.pdf

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/ucm062958.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 premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for transfer sets (excluding sterile connecting devices) used in blood establishments.

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FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)

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