Bill > HR2428

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption, which allows the Food and Drug Administration (FDA) to exempt certain medical devices from effectiveness requirements if they are intended to benefit a limited number of individuals. Specifically, the bill increases the threshold for the number of individuals a device can benefit from fewer than 4,000 to not more than 8,000, meaning more devices for rare conditions could qualify for this exemption. Additionally, within 18 months of the bill becoming law, the FDA is required to issue guidance defining what constitutes "probable benefit" for these devices, a term used to determine eligibility for the exemption.