The HCT/P Modernization Act of 2024 directs the FDA to streamline its oversight of human cell and tissue products by establishing clearer and faster regulatory pathways for manufacturers. The bill requires the FDA to respond within 70 days to manufacturer inquiries about whether their products fall under simplified regulatory categories, and allows manufacturers to request meetings with the FDA's Tissue Reference Group to discuss these classification decisions. Within 90 days of the bill's enactment, the FDA must hold a public meeting with industry, research organizations, academic institutions, and patients to gather input on how key regulatory terms like "minimal manipulation" and "homologous use" should be interpreted. Within 12 months, the FDA must update its regulations and guidance based on that feedback, while providing technical assistance and conducting regular educational workshops for stakeholders. The bill also requires the FDA to submit annual reports to Congress detailing the number and types of classification inquiries received and the regulatory categories assigned to approved products.
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