Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations

The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

The 215-page discussion draft, known as the Diagnostic Accuracy and Innovation Act (DAIA), draws some similarities to another draft bill floated in 2015, as both would create a classification system for in vitro clinical tests (IVCTs), require premarket FDA approval for high-risk tests and create a new center under FDA to regulate these tests.

But unlike the previous bill, DAIA would create a new user fee program, though a summary of the bill notes that “user fees will not be the primary funding source for the new regulatory structure (i.e., user fees will be capped at 30%).”

DAIA seeks to further distinguish the non-overlapping jurisdictions of FDA and CMS, which currently both regulate such diagnostics.

The bill would modernize CMS’ Clinical Laboratory Improvement Amendments (CLIA) program to oversee laboratory operations, which it defines as “all the activities necessary to perform or ‘run’ a developed IVCT, including the preparation of reagents for use in a single CLIA facility, sample preparation, and other pre-analytical processes.”

FDA, meanwhile, would be tasked with regulating “the design, development, and validation of an IVCT as well as the production of an IVCT for distribution to another facility or third-party.”

And as with previous FDA guidance on regulating LDTs, the finalization of which has been delayed, there would be a transition phase to allow industry and regulators to have adequate time to implement the framework:

• IVCTs introduced by laboratories prior to three months before enactment of the bill will be grandfathered and no submission obligations will apply to such IVCTs prior to the effective date of the regulations (i.e., five years after enactment).
• New regulations would be required to be promulgated within three years of enactment, and compliance would be required no later than two years after that (with some opportunity to take advantage of the new system one year post promulgation).

In terms of post-market requirements, the bill’s obligations for test developers will “largely resemble current FDA requirements for in vitro diagnostics, except adverse event reporting will be updated to: (1) limit individual submissions to those events that involve death or imminent threat to public health, and (2) use quarterly summary and trend reporting for all other adverse events, including malfunctions. There will be no overlap of CLIA and FDA requirements.”

Other provisions in the new bill include: FDA will be able to withdraw IVCTs from the market because of risk, and FDA and CMS will still be allowed to inspection and oversee recalls.

Discussion draft summary

Section-by-section overview

Discussion draft text