Bill > HR2427

This bill amends the Federal Food, Drug, and Cosmetic Act, which governs the safety and effectiveness of food and drugs, to improve the process for advisory committees, specifically classification panels, that review premarket submissions for medical devices. The Food and Drug Administration (FDA) will now be required to allow the company submitting a medical device for review to suggest the types of expertise needed for the panel members. The FDA must then consider these suggestions and ensure that the panel includes at least two members with clinical experience relevant to the device and at least one member knowledgeable about the device's technology. Furthermore, the company whose device is being reviewed can designate a representative, who may bring experts, to participate in panel meetings and offer corrections or clarifications, and the bill also mandates adequate time for initial presentations by both the company and the FDA, encouraging open participation.