FDA Solidifies Plans to Regulate LDTs

As expected, the Food and Drug Administration (FDA) is moving forward with plans to regulate laboratory developed tests, or LDTs. The FDA announced its intention to regulate these tests in a recent filing to the Office of Management and Budget. The FDA’s plan to regulate these tests follows an unsuccessful effort last year to enact legislation, known as the Verifying Accurate, Leading-Edge IVCT Development Act, clarifying the Agency’s authority to regulate these tests. ASCP was critical to the effort to prevent the VALID Act from being enacted last year, as thousands of ASCP members used ASCP’s eAdvocacy Center to contact their members of Congress in opposition to the measure.

In addition, the Agency’s regulatory approach to securing oversight authority for LDTS is being supplemented by a recent guidance document the agency released. On June 20, FDA released “voluntary guidance” titled, Oncology Drug Products Used with Certain In Vitro Diagnostic Tests, which focuses on the performance of certain LDTs used to identify patients for treatment with certain oncology drug products.

The FDA’s plans to regulate LDTs was clarified in a recent addition to the Agency’s Unified Agenda, which specifies the regulatory actions federal agencies plan to issue in the near or long term.