Bill > HR2425

This bill amends the Federal Food, Drug, and Cosmetic Act to create a more formalized process for recognizing performance standards for medical devices. It allows any person to request that the Food and Drug Administration (FDA) recognize a standard, or part of a standard, established by a recognized national or international organization as a way for a medical device to meet an FDA requirement. The FDA would then be required to make a decision on the request within 60 days and publicly explain its reasoning, including any scientific or technical basis, for recognizing all, part, or none of the standard. This is a change from the current practice where the FDA may recognize some standards but is not obligated to respond to requests or provide justifications. Additionally, the bill mandates that the FDA provide regular training to its employees who review medical device applications on how to use these recognized standards, and that the FDA publish its principles for recognizing standards, considering factors like their use by other regulatory bodies and the industry, and their potential to harmonize regulations.