Shandra Eisenga Human Cell and Tissue Product Safety Act

HR 1082 establishes new safety standards for human cell and tissue products used in medical treatments. It imposes civil penalties of up to $20,000 per violation (with a maximum $10 million total) for tissue providers who fail to comply with FDA regulations, and requires the FDA to publish educational materials, inspection data, and response times for tissue-related inquiries on its website. The bill also mandates annual public reports on tissue establishment registrations, inspections, and Tissue Reference Group activity, while directing the FDA to host workshops for stakeholders. These measures directly affect tissue providers, the FDA, healthcare professionals, and patients by increasing transparency and accountability in the regulation of these medical products.