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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.


List of Premarket Approvals

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


Related Information


Approvals & Clearances


Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448