The FDA is updating longstanding regulations to include laboratory tests within the same jurisdiction as other types of testing. This move, according to the agency, aims to enhance safety and efficacy standards.
Since 1976, the FDA has not applied legal requirements to most laboratory developed tests due to the Medical Device Amendments. As a result, standards like good manufacturing practices, premarket reviews before patient use, and adverse event reporting have generally not been enforced.
Laboratory developed tests (LDTs) are diagnostic tests produced and utilized within a single laboratory. As noted by the FDA in its recent rule, LDTs were traditionally crafted in small quantities to diagnose rare diseases. Consequently, the FDA historically refrained from enforcing regulations on these tests due to their perceived low-risk nature and application to a limited patient population.
However, the landscape has shifted over time, with LDTs seeing increased usage alongside growing concerns regarding their lack of regulatory oversight.
Today, common LDTs encompass tests for COVID-19, blood levels, and drug abuse. Unlike the 1970s, where LDTs were conducted by laboratory staff with specialized expertise, modern-day tests leverage advanced instrumentation and software to generate results.
