Bass, Berry & Sims attorney Danielle Sloane provided insight for an article published by The Dark Report assessing the impact of the Food and Drug Administration’s (FDA) final rule that increases regulatory oversight for laboratory developed tests (LDTs). Assuming the final rule withstands challenges that have been filed, LDTs will be treated as medical devices and must undertake steps to meet FDA requirements.
“Stepping back from the LDT rule itself, I think the overarching problem is that complying with both CLIA [Clinical Laboratory Improvement Amendments] and the FDA’s rules is simply not feasible and does not make sense,” Danielle said. “In the final LDT rule, the FDA makes a compelling case that clinical laboratory testing has become increasingly important to treatment decisions and patients make important decisions based on test results. However, laboratories already operate on relatively thin margins.”
While the new FDA requirements will be strict, they do not require premarket review process, similar to medical devices. However, that could change if the FDA sees fit.
“Were this to occur, some laboratories may stop offering certain tests and may not put the same amount of resources into test development given the additional burden of obtaining FDA approval. One the flip side, obtaining FDA approval for an LDT and its ‘intended use’ is likely to make it easier for that lab to receive reimbursement from payers and the Medical MolDx program,” Danielle told The Dark Report.
The full article, “Attorneys Assess Impact of FDA’s Final LDT Rule,” was published by The Dark Report on June 10 and is available online (subscription required).
To read further analysis about the FDA’s final rule, click here for content co-authored by Danielle and others at Bass, Berry & Sims.