What is an exempt test?

An exempt test is defined as a diagnostic or screening process that poses a low risk to patients and does not require a premarket submission to the FDA. This designation is significant because it allows certain tests to enter the market more quickly and with fewer regulatory burdens, which can be particularly important for point-of-care testing. These tests are often simple to perform and are typically used in situations where rapid results are essential, such as in emergency or primary care settings.

The classification of these tests as exempt ensures that they can be more readily available, facilitating prompt diagnostic capabilities, which ultimately leads to better patient care in many scenarios.