Bass, Berry & Sims attorney Danielle Sloane provided insight for an articles published by The Dark Report and G2 Intelligence 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.
“From the final rule and the related CMS commentary it is relatively clear that both the FDA and CMS agree that the FDA is better equipped to assess the analytical and clinical validity of individual tests,” Danielle told G2 Intelligence.
“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 for The Dark Report article. “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 articles are linked below:
- “Attorneys Assess Impact of FDA’s Final LDT Rule,” The Dark Report (June 10), subscription required
- “ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas,” G2 Intelligence (June 28), 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.