Zdrowie i gospodarka · 30/09/1999

Suitability Determination for Donors of Human Cellular and Tissue-Based Products

The Food and Drug Administration (FDA) is proposing new regulations to require manufacturers of human cellular and tissue-based products to screen and test the donors of cells and tissue used in those products for risk factors for and clinical evidence of relevant communicable disease agents and diseases. Human cellular and tissue- based products are products that contain or consist of human cells or tissues and that are intended for implantation, transplantation, infusion, or transfer. As part of this regulatory action, the agency is proposing to amend the current good manufacturing practice (CGMP) regulations that apply to human cellular and tissue-based products regulated as drugs, medical devices, and/or biological products to incorporate the new donor-suitability procedures into existing good manufacturing practice (GMP) regulations. The agency is taking this action to provide more appropriate oversight for the wide spectrum of human cellular and tissue-based products that are marketed now or may be marketed in the future. The agency's action would improve protection of the public health and increase public confidence in new technologies, while permitting significant innovatio