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Vaccines, Blood & Biologics

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Premarket Approval (PMA) Process (CBER)

All CBER device applications should be addressed to:

FDA/CBER
1401 Rockville Pike
HFM-99, Room 200N
Rockville, MD 20852-1448

Please do not send CBER device applications to the Center for Devices and Radiological Health (CDRH)

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Key Resources

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Contact Us

  • (800) 835-4709
  • (301) 827-1800

  • Consumer Affairs Branch (CBER)

    Division of Communication and Consumer Affairs

    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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