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Consolidation of Wound Care Products Containing Live Cells

On August 14, 2013, primary responsibility for regulating the following approved products  P950032, P960007, P000036, P010016, (all with product code MGR); H990013 (product code PBD); and H990002 (product code OCE), and all supplements included therein, was transferred from the Office of Device Evaluation, CDRH, to the Office of Tissues, and Advanced Therapies, CBER.  The jurisdictional assignment of these products to CBER is in accordance with section 503(g) of the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (CFR) section 3.4.  This will consolidate primary responsibility for regulating wound care products containing live cells in CBER.

Submissions related to these approved products should be sent to CBER's document control room at the following address:

Center for Biologics Evaluation and Research
Office of Tissues, and Advanced Therapies
Document Control Center
10903 New Hampshire Avenue
Silver Spring, MD. 20993-0002

Phone number: 240-402-8190

For specific assignment information within CBER, sponsors of transferred products and related submissions may contact Lori Tull at 240-402-8361 or via email at Lori.Tull@fda.hhs.gov


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