What must be demonstrated for a medical device to receive market approval?

The requirement for a medical device to receive market approval is grounded in the necessity to demonstrate that the device is safe, effective, and compliant with relevant regulatory standards. This is crucial for ensuring patient safety and maintaining public health. Regulatory bodies, such as the FDA in the United States or the European Medicines Agency in Europe, primarily focus on the device's safety profile—meaning it does not pose undue harm to users—and its effectiveness, which involves proving that the device performs its intended function effectively.

Compliance with relevant regulatory standards encompasses a wide range of guidelines that govern device design, manufacturing processes, quality control, and post-market surveillance, among others. These standards are established to ensure that medical devices maintain consistency in quality and performance over time.

In contrast, while factors like cost-effectiveness, technological advancement, and marketing strategies can play a role in the commercial success of a medical device, they are not prerequisites for market approval. Regulatory authorities do not consider pricing, comparative technology advantage, or marketing efforts in their evaluation process for safety and efficacy. Therefore, focusing exclusively on these elements would not fulfill the legal and ethical obligation to ensure that devices are safe for patient use and adequately perform their intended medical functions.