Vaccines, Blood & Biologics
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.
Premarket Approval (PMA) Process (CBER)
Development & Approval Process information