Medical device recalls in the United States are mandated by which agency?

The agency responsible for mandating medical device recalls in the United States is the Food and Drug Administration (FDA). The FDA plays a critical role in ensuring the safety and effectiveness of medical devices, overseeing their approval, and monitoring their performance once they are on the market. When a safety concern arises regarding a medical device—whether due to manufacturing defects, malfunctions, or adverse health effects—the FDA has the authority to initiate a recall to protect public health. This process involves working closely with manufacturers to manage the recall, which can include notifying healthcare providers and patients, providing guidance on the use or disposal of the affected devices, and ensuring that necessary corrective actions are taken.

In contrast, while the Centers for Disease Control and Prevention (CDC) is focused on public health and disease prevention, and the Occupational Safety and Health Administration (OSHA) oversees workplace safety, neither has the jurisdiction to require medical device recalls. The Environmental Protection Agency (EPA) is primarily concerned with environmental protection, including regulation of hazardous substances, and does not actively manage medical device safety or recalls.