Regulatory Affairs Certification (RAC) Practice Exam

According to 21 CFR 820, how is a clinical study aimed at establishing device safety and effectiveness defined?

1. A Design validation

2. B Risk assessment

3. C Quality control

4. D Regulatory compliance

The correct answer is: A Design validation

A clinical study aimed at establishing device safety and effectiveness is defined as a design validation according to 21 CFR 820. Design validation involves confirming that the design of a medical device meets the user's needs and intended uses, which is specifically assessed through systematic evaluations and tests, including clinical studies. The main goal is to ensure that the device functions as intended in the actual use environment and meets safety and effectiveness criteria, which is essential for regulatory submissions. Design validation is a critical part of the quality management system outlined in the Quality System Regulation (QSR). It is distinct from the other concepts; for example, risk assessment focuses on identifying and mitigating potential risks associated with the device but does not directly concern the validation of the design itself. Quality control refers to the processes involved in maintaining the integrity of the manufacturing quality but does not encompass the broader scope of assessing safety and effectiveness through clinical studies. Regulatory compliance signifies adherence to applicable laws and regulations, but it does not specifically define the purpose of clinical studies in validating a device's design. Therefore, the definition of a clinical study aimed at device safety and effectiveness fits most appropriately within the concept of design validation.