FDA Policy/General

Guide on Cell/Tissue-Based Product Regulatory Considerations

FDA has released a guidance on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use.” The document provides the agency’s criterion for determining minimal manipulation and homologous use. It also outlines that over the next 36 months, FDA intends to exercise enforcement discretion “under limited conditions with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.”

The guidance defines minimal manipulation to mean:

1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement;

2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.

The guidance defines homologous use to mean the “repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor... In applying the homologous use criterion, FDA will determine what the intended use of the HCT/P is, as reflected by the labeling, advertising, and other indications of a manufacturer’s objective intent, and will then apply the homologous use definition.” Additionally, the guidance provides examples of different types of HCT/Ps and how the regulations apply to them.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome