Shandra Eisenga Human Cell and Tissue Product Safety Act

The Shandra Eisenga Human Cell and Tissue Product Safety Act would create civil penalties for companies and organizations that violate FDA regulations governing the donation, handling, and distribution of human cell and tissue products. These products include articles containing human cells or tissues intended for transplant or medical use. The bill specifically targets violations related to donor eligibility requirements and manufacturing standards known as current good tissue practice.

Beyond penalties, the bill would require the FDA to conduct educational workshops for stakeholders in the tissue and organ donation industry, establish a public comment process, and develop recommendations for Congress on how to better regulate these products. The FDA would need to create educational materials for healthcare professionals about organ, tissue, and eye donations, and publish information about its Tissue Reference Group, which advises on human cell and tissue products.

For three years following enactment, the FDA would be required to annually publish data on inquiries submitted to the Tissue Reference Group and information about FDA registrations and inspections of tissue manufacturers. These transparency and education measures aim to improve safety standards and stakeholder understanding of regulations governing products that are critical for transplants and regenerative medicine treatments.

The bill passed the House and is currently in committee in the Senate, where it would need to be approved before moving to the President for signature.