Which are the two primary categories of medical devices based on risk?

The correct answer identifies the two primary categories of medical devices based on risk: non-invasive and invasive devices. This classification is crucial because it helps to assess the potential risks associated with the use of medical devices and informs regulatory pathways for their approval and monitoring.

Non-invasive devices are those that do not penetrate the body or disrupt the skin barrier. Examples include external monitors and simple diagnostic tools. Because these devices have lower inherent risks of harm, their regulation may be less stringent compared to invasive devices.

In contrast, invasive devices enter the body and have a higher potential for causing adverse effects, such as infection or injury. These devices include surgical instruments, catheters, and implants. Due to the higher risks, invasive devices require more rigorous testing and oversight to ensure safety and effectiveness.

Understanding the distinction between non-invasive and invasive devices is fundamental for healthcare professionals, manufacturers, and regulatory bodies as they navigate the complexities of device development, approval, and usage. The other options represent different criteria for categorizing devices, but they do not specifically address the risk-based classification as effectively as the distinction between non-invasive and invasive devices does.