The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests developed by a laboratory and offered as a diagnostic service by that laboratory are regulated at the federal level by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA).
This regulatory dichotomy appears to be ending. In the past few months, FDA officials have repeatedly stated that they intend for the agency to regulate at least some subset of laboratory-developed tests (LDTs) as medical devices. FDA regulation of LDTs—if it occurs—could have a significant impact on the diagnostic industry, pharmaceutical companies, the healthcare system, and patients. Indeed, even before regulation of laboratories begins, the prospect of FDA exercising jurisdiction will affect decisions by laboratories and investors.
From 1976, when FDA received authority to regulate devices, until 1992, FDA expressed no interest in regulating LDTs. In 1992, the agency said for the first time that it had the authority to regulate LDTs as devices. Five years later, FDA reiterated that it had the legal power to regulate LDTs, but was choosing to “exercise enforcement discretion,” and would leave LDTs alone. The hands-off approach largely remained in effect until the middle of the last decade. Then, FDA intermittently sought to regulate certain individual tests. In 2006 FDA proposed a broader approach, stating that it intended to regulate a narrow subset of LDTs, which it called in vitro diagnostic multivariate index assays (IVDMIAs).