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 Approvals and Humanitarian Device Exemptions with Supporting Documents
- Complete List of Currently Approved Premarket Approvals (PMAs)
- Premarket Approval (PMA) for CBER-Regulated Products
Development & Approval Process information