Devices
The Center for Biologics Evaluation and Research (CBER) regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all HIV test kits used both to screen donor blood, blood components and cellular products, and to diagnose, treat and monitor persons with HIV and AIDs.
Approval Process and Related Information
- Device Application Submission
- Devices Regulated by CBER
- Forms
- Medical Device User Fee and Modernization Act (MDUFMA)
Approved Products
- Approved Substantially Equivalent 510(k) Devices
- Approved Premarket Approval (PMA) Device Applications
- 510k Blood Establishment Computer Software
- Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
- Donor Screening Tests for Testing HCT/P Donors
Device Guidances, Rules and Other Publications