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  1. Center for Biologics Evaluation and Research (CBER)

CBER Product Jurisdiction

CBER regulates a variety of different product types including biologics such as allergenics, blood and blood products, cellular & gene therapies, tissue and tissue-based products, vaccines and xenotransplantation products. We also regulate some devices including selected in vitro diagnostics and devices that manufacture a biologic at the point of care, as well as a small number of drug products related to blood banking or cellular therapies. These products are distributed among three product review offices within CBER: Office of Vaccines Research and Review (OVRR), Office of Tissues and Advanced Therapies (OTAT) and the Office of Blood Research and Review (OBRR).  CBER’s allergenic products, infectious disease vaccines and live biotherapeutic (probiotic) therapies are regulated by OVRR. OTAT regulates cell, tissue and gene therapies as well as therapeutic vaccines for various disease indications. OBRR regulates blood and blood products, including plasma derivatives and their recombinant analogues. OBRR is also responsible for the regulation of blood donor screening assays and retroviral diagnostic tests.

CBER’s product jurisdiction officer provides a resource for sponsors and research investigators who have questions about how their product is classified (e.g., a biologic, drug, device, combination, 361 HCT/P or other), who regulates it (which center or which office within CBER), or which regulatory path/requirements apply. Classification and jurisdiction determinations can be made informally or formally. Informal assignment questions can be submitted directly to CBER’s jurisdiction officer using the e-mail or phone contact information provided below.    

CBER Product Jurisdiction Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
WO71-7240
Silver Spring, MD 20993-0002

Phone: 240-402-7912
Email: CBERProductJurisdiction@fda.hhs.gov

Formal assignment requests require the submission of a Request for Designation Document (RFD) to FDA’s Office of Combination Products.   

CBER 513(g)

CBER’s 513(g) coordinator oversees the review and response to Section 513(g) “Requests for Information under the Federal Food, Drug, and Cosmetic Act (FD&C Act),” that have been submitted to CBER.  These requests are regarding the class in which a device has been classified or the requirements applicable to a device under the FD&C Act.

For information on 513(g) user fees, please refer to the following guidance document:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209852.htm

Please submit CBER 513(g) submissions to :

CBER 513(g) Coordinator
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
WO71-G112
Silver Spring, MD 20993-0002

 
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