What Are In Vitro Diagnostic Tests and How Are They Regulated?
Jul 20, 2022
Oversight may not be keeping pace with changes in the diagnostics market Health care providers rely on a variety of tools to diagnose conditions and guide treatment decisions. Among the most common and widely used are in vitro diagnostics (IVDs), which are clinical tests that analyze samples taken from the human body. Patients may receive—or forgo—medical care based on diagnostic test results, making it critically important that tests are reliable. These tests are regulated by the Food and Drug Administration as medical devices, which means manufacturers must submit studies confirming a test’s accuracy and usefulness in diagnosing a particular condition before bringing it to market. However, FDA has historically exempted from this requirement any IVDs that are developed and used within the same laboratory, often referred to as laboratory-developed tests (LDTs). Though some test developers dispute that FDA has jurisdiction over LDTs—arguing that the tes...
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