Summary
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry\" dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.
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