Certified Healthcare Leader (CHL) Exam 2026 – 400 Free Practice Questions to Pass the Exam

The Food and Drug Administration (FDA) is the agency responsible for regulating the manufacture of all medical devices. This regulation encompasses the entire lifecycle of medical devices, from initial development through the approval process and into post-market surveillance. The FDA establishes guidelines and requirements that ensure medical devices are safe, effective, and manufactured according to high standards of quality.

The FDA's role is vital in maintaining public health, as it evaluates the safety and effectiveness of devices through rigorous testing and clinical trials. Manufacturers are required to submit data to the FDA demonstrating that their devices meet necessary safety and efficacy standards before they can be marketed. Additionally, the FDA oversees the compliance of manufacturers with regulations such as Good Manufacturing Practices (GMP), ensuring that devices are consistently produced and controlled according to quality standards.

In contrast, the other agencies focus on different aspects of health and safety. The Centers for Medicare & Medicaid Services (CMS) primarily deals with the administration of healthcare programs and payment systems. The Centers for Disease Control and Prevention (CDC) primarily focuses on public health and disease prevention. The Occupational Safety and Health Administration (OSHA) is concerned with workplace safety and health regulations. Each of these agencies has important roles, but they do not have the broad regulatory authority over medical device manufacturers that