Regulatory Affairs Certification (RAC) Practice Exam

What is the primary legal responsibility of FDA regarding new drugs and devices?

1. Ensuring quality production processes

2. Guaranteeing market success

3. Verifying safety and efficacy

4. Controlling pricing

The correct answer is: Verifying safety and efficacy

The primary legal responsibility of the FDA regarding new drugs and devices is to verify their safety and efficacy before they can be marketed to the public. This requirement is rooted in the Federal Food, Drug, and Cosmetic Act, which mandates that any new drug or medical device must demonstrate that it is safe for use and effective for its intended purpose through rigorous scientific evaluation. This involves reviewing clinical trial data, assessing manufacturing practices, and examining labeling to ensure that consumers have reliable information about the products. While other functions, such as ensuring quality production processes, are important and relevant to the FDA's mission, they fall under the umbrella of regulatory oversight rather than being the primary legal obligation. The FDA does not guarantee market success for any product; rather, it focuses on the assessment of safety and efficacy. Additionally, the agency does not control pricing, as pricing is determined by market factors and is not a part of the FDA's regulatory functions. The emphasis on safety and efficacy is crucial to protect public health and maintain trust in medical products, underscoring its significance in the FDA’s responsibilities.