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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)

The following products are regulated as Premarket Approvals (PMAs): Devices associated with blood donor testing.

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List of Premarket Approvals

Information is arranged in alphabetical order by the name of the applicant.

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Related Information

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002
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