The FDA will not finalize its 2014 draft guidance on “FDA Notification and Medical Device Reporting of Laboratory Developed Tests” any time soon due to the changing political administration, according to a statement the agency provided to GenomeWeb. Intended to balance “patient protection with continued access and innovation,” the draft guidance is unpopular in the laboratory and pathologist communities, which view lab-developed tests (LDTs) as services that should be regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, rather than medical devices within the FDA’s regulatory purview. The FDA’s hesitation stems, in part, from the uncertainty of the new political landscape, including the views of the as-of-yet unnamed incoming HHS Secretary.
The FDA has taken the position that LDTs are subject to its enforcement discretion pursuant to the Medical Device Amendments because they are intended for clinical use and designed, manufactured, and used within one laboratory (see FDA seeks notification of lab developed tests, October 3, 2014). According to GenomeWeb, the FDA believes that gaps in the CLIA-authorized system present a public health risk. However, some senators from the Republican party—which will control Congress—believe the agency is “too plodding to keep up with innovation in the molecular diagnostics space.”
The agency continues to emphasize the importance of its role in regulating LDTs and is considering issuing best practices, rather than a final guidance. Senator Lamar Alexander (R-Tenn) and Representative Fred Upton (R-Mich) applauded the FDA’s decision not to finalize the guidance in the near future, while the American Clinical Laboratory Association (ACLA) called it “a victory for diagnostic innovation and most importantly, patients.”