Who is responsible for monitoring adverse events related to medical devices in the U.S.?

The Food and Drug Administration (FDA) is responsible for monitoring adverse events related to medical devices in the United States. This responsibility includes the oversight of both premarket approvals and post-market surveillance. The FDA collects and analyzes reports of adverse events through various programs, including the Manufacturer and User Facility Device Experience (MAUDE) database, which enables the agency to identify trends and take necessary regulatory actions to ensure the safety of medical devices.

In the context of federal health agencies, the Department of Health and Human Services plays a broader role in public health and welfare but does not specifically handle adverse event monitoring for medical devices. The Centers for Disease Control and Prevention primarily focuses on public health issues and disease prevention rather than device safety. The National Institutes of Health is involved in medical research but doesn't have a primary function related to the monitoring of adverse events associated with medical devices. This delineation of responsibilities underscores the FDA's crucial role in ensuring the safety and effectiveness of medical technologies in the market.