Bill > S2188

This bill, known as the Rare Disease Innovation Act, aims to make it easier for certain medical devices to be approved for use by expanding the humanitarian device exemption. Currently, the Food and Drug Administration (FDA) can exempt devices that are intended to help fewer than 4,000 people from needing to prove their effectiveness. This bill would increase that number to devices intended to help not more than 8,000 individuals, which is significant because it doubles the number of people who could potentially benefit from these specialized devices without the full, often lengthy and expensive, effectiveness testing. Within 18 months of the bill becoming law, the FDA must also clearly define what "probable benefit" means for these devices, a crucial term used in determining eligibility for the exemption. Furthermore, the FDA will be required to report to Congress every five years on how this expansion of the humanitarian device exception is impacting the availability of these devices.