A draft bill in the U.S. House of Representatives would grant the Food and Drug Administration (FDA) new powers to inspect laboratories and create new reporting requirements that essentially redefine as medical device manufacturers hospitals, commercial laboratories, and physician office laboratories that perform laboratory developed tests (LDT), according to AACC comments on the bill. “Clinical laboratories are not medical device manufacturers and cannot afford the additional regulatory and financial costs associated with this draft legislation,” the association wrote. “As proposed, the current legislative draft could result in an anti-competitive system that favors the few laboratories with sufficient resources to comply with FDA requirements that were developed for manufacturers, thereby creating a situation wherein testing costs could rise. … Any change in the [in vitro diagnostics] company submission process should be considered separately from LDT oversight.”
According to the bill’s sponsors, Rep. Larry Bucshon, MD, R-Ind., and Rep. Diana DeGette, D-Colo., the Diagnostic Accuracy and Innovation Act tackles “long-standing issues” with diagnostic test regulations, bringing “much-needed certainty to patients, providers, and industry.” The bill would take a risk-based approach and apply the same regulatory principles to the same activity regardless of where the test is developed. This would be accomplished by creating a new regulatory structure in FDA for so-called in vitro clinical tests.
AACC did agree with certain provisions in the bill, such as the need for laboratories to demonstrate analytical and clinical validity of LDTs. Likewise AACC has long supported a risk-based level of oversight for LDTs. Moderate and low-risk LDTs—which represent the majority of such tests—should remain exclusively under CLIA, while tests in the high-risk category should be jointly regulated by FDA and the Centers for Medicare and Medicaid Services, according to the association.