Shandra Eisenga Human Cell and Tissue Product Safety Act

Plain-English summary

Shandra Eisenga Human Cell and Tissue Product Safety Act This bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also requires the Food and Drug Administration (FDA) to report on the regulation of these products and to provide related information to stakeholders. ( Human cell and tissue products are articles containing or consisting of human cells or tissues that are intended for use in a human recipient. ) Specifically, the bill establishes civil penalties for violations of the FDA’s regulations on donor eligibility and current good tissue practice for manufacturing and distributing human cell and tissue products.

Deterministically condensed from the official CRS summary; verify details in the official record.