When history is written, acceleration of the longstanding effort to eliminate the authority of the U.S. Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs) may be remembers as one of the unexpected impacts of the COVID-19 pandemic. The public health emergency underlined the need to bring innovative new diagnostic tests to market more expeditiously. In fact, many of the most significant COVID-19 tests to receive Emergency Use Authorization were LDTs created by Quest, LabCorp, Abbott and other major testing laboratories. And now the epicenter of the movement may be shifting back to Congress with the reintroduced of the so-called VITAL Act. The VITAL Act First introduced by Senator Rand Paul (R-KY) in March 2020, the Verified Innovative Testing in American Laboratories (VITAL) Act would transfer the source of regulation of LDTs from the FDA (under the Food, Drug & Cosmetics Act (FDCA)) to the Secretary of the US Health and Human Services (HHS) (under the Public Health Services Act). While it may sound like legal nuance, this is important because it would end once and for all the FDA’s claims that its regulatory authority over medical devices under the FDCA extends to LDTs. Paul, who also introduced […]