Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entity establishments that manufacture HCT/Ps better understand the comprehensive regulatory framework for HCT/Ps set forth in the regulations and comply with certain HCT/P- related final rules. The SECG announced in this notice supersedes the SECG of the same title dated August 2007.
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