Certified Ambulatory Perianesthesia Nurse (CAPA) Practice Exam

Which agency requires reporting serious injuries from medical products within ten days?

1. American Medical Association

2. Occupational Safety and Health Administration

3. Food and Drug Administration

4. Centers for Disease Control and Prevention

The correct answer is: Food and Drug Administration

The Food and Drug Administration (FDA) is the agency that requires healthcare providers and manufacturers to report serious injuries related to medical products within ten days. This reporting guideline is part of the FDA’s responsibilities in monitoring the safety of medical devices, pharmaceuticals, and other healthcare products after they are approved for public use. The requirement for timely reporting—specifically within ten days—is essential for the FDA to assess the safety and efficacy of these products and to take necessary actions to protect public health if significant risks are identified. This process facilitates a rapid response to emerging safety concerns, ensuring that any necessary safety alerts or recalls can be communicated promptly. In contrast, the other agencies listed do not have this specific requirement related to medical product injury reporting. The American Medical Association primarily focuses on physician advocacy and medical ethics rather than product safety reporting. The Occupational Safety and Health Administration is concerned with workplace safety and health, which does not encompass the reporting of injuries from medical products in the same manner as the FDA. The Centers for Disease Control and Prevention focuses on public health and disease prevention but does not specifically regulate medical products to the extent that the FDA does.