User:LulieBella/Point-of-care testing

Regulatory in the U.S.
The Clinical Laboratory Improvement Amendments (CLIA) regulate any laboratory testing and require laboratories to obtain certificates to do any testing on human specimens for health assessment or to diagnose, prevent, or treat disease. Three federal agencies partner together to cover the responsibilities put forward in the regulations: the Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC).

Food and Drug Administration (FDA)
In vitro diagnostic (IVD) products use the same categorization as medical devices (Class I, II, and III) to assure safety and effectiveness. Regulatory controls and premarket approval process are determined by this classification, with Class I being the lowest risk (least regulated) and Class III being the highest risk (most regulated).

Under the CLIA, it is the role of the FDA to assess the complexity of the in vitro laboratory diagnostic tests. Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request. Manufacturers can apply for CLIA waivers during this premarket approval/clearance process. Tests that are already cleared or approved for home use or are waived by 42 CRF 293.15(c), are classified as waived. Otherwise, the tests are either classified as moderate or high complexity based on seven categorization criteria listed in 42 CFR 493.17. If the test is classified as moderate, the manufacturer may request the test be waived through the CLIA Waiver by Application. The application must show that the test meets the criteria in 42 U.S.C. § 263a(d)(3), that the test is simple and will not cause harm to the patient if performed incorrectly.

These test classifications determine the certifications needed for laboratories to perform said tests. Waived tests require the least regulation, while moderate to high complexity tests require higher regulation and standards within the laboratory.

Center for Medicaid Services (CMS)
Under CLIA, it is the role of CMS to issue laboratory certificates and monitor, inspect, and enforce laboratory regulatory compliance based on the tests being performed. In total, CMS covers 260,000 laboratories.

Centers for Disease Control and Prevention (CDC)
The CDC focuses on the analysis, research, and technical assistance within the CLIA partnership. In particular, the CDC establishes technical standards and guidelines, conducting studies, monitoring practices, and developing resources. In addition, the CDC manages the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC is made up of experts in many specialties throughout clinical and anatomic pathology that provide guidance and advice on general issues within laboratory science.

The CDC specifically acknowledges that point-of-care testing simply describes the location at which the testing is performed and not the complexity of the test itself. With technological innovation, more complex tests will be able to be performed at the bedside that may not be CLIA-waived like some other at-home point of care tests that the FDA has waived such as urine dipsticks.