Premarket Approval (PMA) Process (CBER)
All CBER device applications should be addressed to:
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002
Please do not send CBER device applications to the Center for Devices and Radiological Health (CDRH)
Key Resources
- Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)
CBER Premarket Approvals - PMA Approvals
CDRH Premarket Approvals - How to Study and Market Your Device
Information about how to market your medical device.
Sub-Topic Paragraphs
Follow CBER
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber