Shandra Eisenga Human Cell and Tissue Product Safety Act

The Shandra Eisenga Human Cell and Tissue Product Safety Act would authorize a nationwide, evidence-based education campaign led by the Department of Health and Human Services (via the FDA) to inform health care providers and other professionals about human cell and tissue products (HCTPs), including donation, donor screening tests, and related donation issues. It also adds civil penalties for violations of existing regulations governing HCTPs, increases regulatory transparency by requiring FDA to publish information about Tissue Reference Group activities and inspections, and creates new requirements for stakeholder education and public engagement. Additionally, the bill directs a public docket and a congressionally-led report to consider modernization of the regulation of HCTPs, including data-generating practices and considerations around minimal manipulation and homologous use. The overall aim is to improve awareness, accountability, and regulatory clarity around HCTPs while ensuring public health protections.