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 Cellular, Tissue and Gene 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 Cellular, Tissue and Gene Therapy
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448
For specific assignment information within CBER, sponsors of transferred products and related submissions may contact Patrick Riggins at 301-827-5366 or Patrick.Riggins@FDA.HHS.GOV.