An analysis of the FDA's approach to the regulation of cadaveric tissues

This thesis is an analysis of the Food & Drug Administration's (FDA) approach to the regulations pertaining to cadaveric and engineered tissues in terms of controlling and understanding product variation and quality. The FDA regulations pertaining to the processing of cadaveric tissues focus on the prevention of contamination and cross contamination, and the regulations pertaining to engineered tissues focus on the total quality.Cadaveric tissues must be recovered under controlled conditions and minimally manipulated and processed to prevent contamination. Minimal manipulation may be thought of as a quality standard that companies must ensure, yet this standard is not well-defined by the FDA. The balance between preventing contamination and keeping cadaveric tissues minimally manipulated is difficult to achieve without a good understanding of product variation and quality. In order to keep cadaveric tissues safe from contamination, it may be necessary to more than minimally manipulate tissue by an undefined amount.