You are here

Regulation

AdvaMedDx promotes the value of innovative, safe and effective diagnostic tests and advocates for risk-based regulation of all diagnostics. Currently, the Food and Drug Administration (FDA) has regulatory oversight of all diagnostic tests that are considered to be medical devices, including those manufactured and sold as kits to laboratories, physician offices and patients. Most tests that are developed and offered within a particular laboratory, called laboratory developed tests – LDTs – are regulated through the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments, or CLIA. The FDA has indicated plans to apply a risk based regulatory approach to LDTs, and the agency is developing a framework for implementation.

AdvaMedDx advocates for the appropriate regulation of diagnostics:

  • Focus FDA's limited resources on tests that pose the highest risk to patients - regardless of where such tests are developed.
  • Expedite patient access to lower risk tests by more efficient use of pre-market review process, including exemptions for well-established tests.
  • Ensure review of higher risk diagnostics for safety and effectiveness by extending FDA oversight to higher risk tests developed by laboratories.