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Requests for Designation should be sent to:
Office of Combination Products
Food and Drug Administration
15800
Crabbs Branch Way (HFG-3)
Suite 200
Rockville, MD 20855
(301) 427-1934
fax (301) 427-1935
email: combination@fda.gov
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to Section 3.6 Product Jurisdiction Officer
Center for Biologics Evaluation and Research (CBER)
Center Contact:
Sheryl Lard Whiteford, Ph.D.
Ombudsman
Email: sherry.lard@fda.hhs.gov
Telephone:
301-827-0379
Fax: 301-827-2920
Center for Devices and Radiological Health (CDRH)
Center Contact:
Miriam Provost, Ph.D.
Deputy Director for Engineering and Science Review
E-mail: miriam.provost@fda.hhs.gov
Telephone: 240-276-3983
Fax: 240-276-3977
Center for Drug Evaluation and Research (CDER)
Center Contact:
Virginia L. Behr
Acting Ombudsman
Email: virginia.behr@fda.hhs.gov
Telephone:
301-443-5581
Fax: 301-827-4312