Bradley Thompson Quoted On FDA Regulation of Laboratory Developed Tests

IVD Technology

Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article in IVD Technology magazine about the issue of FDA Regulation of Laboratory Developed Tests.

Thompson made the remarks during his presentation at the 36th annual meeting of the Association of Medical Diagnostic Manufacturers (AMDM).

The article, "AMDM Examines Important IVD Issues," reported on Thompson's presentation, titled, "FDA Regulation of Laboratory Developed Tests (LDT)." In the presentation, Thompson said that FDA should regulate all diagnostics, including LDTs, and that three reasons often given for not doing so are invalid. The three reasons have been that FDA lacks resources to regulate LDTs, that FDA regulation will discourage innovation, and that CLIA regulation is enough.