diagnostic diagnostics lab developed testsDiagnostic and lab-developed test (LDT) regulations could soon receive a significant overhaul. RAPS reported this week that a bipartisan duo, Rep. Larry Buchson, M.D. (R-IN) and Diana DeGetter (D-CO), released a discussion draft for a bill proposing a new path for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

The draft, named the Diagnostic Accuracy and Innovation Act (DAIA), 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.”1 Additionally, the discussion draft would “create a new user fee program…[though] user fees will not be the primary funding source for the new regulatory structure (i.e., user fees will be capped at 30%).” Under this bill, the CMS’ Clinical Laboratory Improvement Amendments (CLIA) program to oversee laboratory operations would be modernized. Furthermore, FDA’s responsibilities would expand to regulate “the design, development, and validation of an IVCT as well as the production of an IVCT for distribution to another facility or third-party”

Assuming the draft discussion advances and FDA issues a full guidance, a transition phase will allow the industry and regulators time to “implement the following 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).” 1

Regarding other post-market requirements, test developer’s responsibilities will “largely resemble current FDA requirements for in vitro diagnostics, except adverse event reporting will be updates 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.”2 We will continue to monitor the advancement of this draft discussion and the possible impact on diagnostic and lab-developed test regulations. Check back to the Pearl Pathways blog or follow us on Twitter for more immediate updates.