Bill > HR2423

This bill amends the Federal Food, Drug, and Cosmetic Act, which is the primary law governing the safety and effectiveness of food, drugs, and medical devices in the United States, to broaden the definition of "valid scientific evidence" that the Food and Drug Administration (FDA) can consider when determining if a medical device is effective. Specifically, it clarifies that well-documented case histories, including registry data collected under a proper plan, and studies published in peer-reviewed journals can be considered valid scientific evidence, potentially reducing the need for extensive clinical investigations in some cases. The bill also allows for the consideration of data collected in other countries, provided it meets the same standards. Furthermore, if the FDA requests the underlying data from a peer-reviewed study to assess a device's effectiveness, it must provide a written explanation for the request and consider the least burdensome methods for evaluation; if the requested data is unavailable, the FDA will still consider the published study as part of the overall evidence for the device.