Laboratories are subject to regulation by the Clinical Laboratory Improvement Amendments (CLIA) and are often referred to as clinical laboratories. In May 2024, the Food and Drug Administration announced they were amending their regulations with regard to laboratory developed tests oversight, such that laboratory developed tests are now subject to certain FDA regulations, including premarket notification or approval (with some exceptions). CLIA regulations define three categories of test complexity. From least to most complex, tests may be categorized as: waived tests, moderate-complexity tests (including Provider-Performed Microscopy (PPM) tests), or high-complexity tests. A test may be categorized as waived if it is cleared for at home or over the counter use, it employs simple and accurate methodologies such that erroneous results are unlikely, and/or it poses no reasonable risk of harm to the patient when used incorrectly.