Shandra Eisenga Human Cell and Tissue Product Safety Act

Shandra Eisenga Human Cell and Tissue Product Safety Act

This bill requires federal agencies to update guidance, regulations, and educational materials about transplants involving human cell and tissue products, particularly with respect to safety and eligibility standards.

Specifically, the Department of Health and Human Services must support the development of educational materials for health care providers about issues relating to organ, tissue, and eye donations; screening tests; and other aspects of donations. The Food and Drug Administration (FDA) must review current guidance on donor eligibility and, if appropriate, update it with information on how to reduce the spread of tuberculosis or sepsis in association with donations. The FDA must also publish information about its Tissue Reference Group and data about FDA inspections and registrations of human cell and tissue establishments.

The bill also establishes specific civil penalties for violations of regulations governing procedures for human cell and tissue products. The FDA must consider and recommend ways to update these regulations after a public comment period.