Learn about diagnostic test regulations

For international readers outside of U.S., this paper can be used as a case study resource.

Understanding the regulatory environment for diagnostic tests is critical to the successful creation and launch of all diagnostic tests—in-vitro diagnostics (IVDs) and laboratory developed tests (LDTs).

In this paper authored by the Arizona State University’s College of Health Solutions, "Regulatory guidance for laboratories that design and implement diagnostic tests for clinical use", learn about:

  • The role of the United States Food and Drug Administration (FDA) and Health and Human Services (HHS) in regulating IVDs and LDTs
  • FDA regulations related to IVD tests used for Research Use Only (RUO) and Investigational Use Only (IUO)
  • The role of the Centers for Medicare & Medicaid Services (CMS) in laboratory processes associated with diagnostics tests

About the Arizona State University College of Health Solutions

Recognized by U.S. News & World Report as the country’s most innovative school, Arizona State University (ASU) is where students and faculty work together to advance research, strategic partnerships, entrepreneurship, and economic development.

The ASU College of Health Solutions is dedicated to translating scientific health research and discovery into practical intervention. Their Master’s Degree in Biomedical Diagnostics is designed to address the role of diagnostics in clinical and research decision-making. With the only program of its kind in the world, ASU is dedicated to being the academic and intellectual center of the diagnostics industry.

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