NBCSN Nationally Certified School Nurse Practice Exam 2026 - Free School Nurse Certification Practice Questions and Study Guide

The approval of Automated External Defibrillators (AEDs) is the responsibility of the Federal Drug Administration (FDA). The FDA is the agency that regulates and oversees medical devices in the United States, ensuring that they are safe and effective for public use. This includes not only AEDs but also a wide range of other medical devices and products.

The FDA's rigorous evaluation process must be completed before any manufacturer can market an AED. This process includes reviewing data regarding the device's effectiveness, safety, and manufacturing practices. AEDs are considered critical life-saving devices in cases of sudden cardiac arrest, and their approval by the FDA is crucial for establishing public trust in their reliability and effectiveness.

Other agencies mentioned, such as the World Health Organization and the Centers for Disease Control, focus on public health and disease prevention rather than device approval. The American Medical Association, while influential in promoting medical standards and ethics, does not have a role in the formal approval process of medical devices like AEDs. Thus, the FDA's role is central and essential in ensuring that AEDs meet the necessary criteria for clinical use.