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  1. Development & Approval Process (CBER)

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)


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