Following years of debate on the issue, FDA is floating a legislative proposal that would cement the agency’s authority to regulate high-risk clinical laboratory diagnostics – including laboratory-developed tests and in-vitro diagnostics – under a risk-based framework in which lower-risk tests could go through FDA’s new, voluntary precertification pathway. The plan drew praise from device test manufacturers, clinical labs and patient advocates, who had been divided on what path FDA should take to regulate clinical lab tests that historically fell in CMS’ turf.
FDA’s proposal, dated Aug. 3, diverges from legislation pending on Capitol Hill that would set up three risk categories of tests and establish a new FDA center to oversee the space. FDA’s plan envisions just two risk categories – first of a kind, screening, cross‐labeled devices that would be subject to FDA premarket review and low-risk devices that could voluntarily go through FDA’s precertification process. FDA’s legislative framework also rejects lawmakers’ idea of setting up a new agency center to oversee clinical laboratory tests.
FDA’s proposal drew praise from a wide swath of stakeholders. In a letter sent to the heads of the House Energy & Commerce and Senate health committees on Wednesday (Aug. 8), twelve diverse medical stakeholders, including AdvaMedDx, Friends of Cancer Research and American Clinical Laboratory Association, wrote that the FDA proposal “represents an important and necessary next step in the pursuit of comprehensive legislative reform.”
AdvaMeDx, in a separate statement, wrote even more glowing praise of FDA’s proposed alternative to the Diagnostic Accuracy and Innovation Act (DAIA) introduced by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) in 2017.
“AdvaMedDx has long supported FDA oversight of all diagnostics, including LDTs, under a risk-based approach that promotes the public health and innovation,” wrote Susan Van Meter, executive director of AdvaMeDx.
“The FDA’s technical assistance in support of a modernized and predictable, regulatory framework for all diagnostic tests, will allow further progress on Capitol Hill toward enacting legislation to speed the pace and reach of cutting edge diagnostics, allowing patients to benefit more broadly, rapidly, and confidently, from the latest diagnostic technologies,” she said.
In its draft legislative plan, FDA stresses a need for striking a balance between creating an efficient pathway to market for new tests while maintaining scrupulous FDA oversight and product accuracy. To strike that balance, the agency recommends creating an optional precertification program, where precertified test developers would not be subject to premarket review.
“Ultimately, this would create an efficient, least burdensome pathway for products for two years, at which time precertification would be reviewed to provide continuing assurance that [IVDs] meet statutory standards,” the agency wrote.
The FDA’s precertification idea is a major change to the DAIA discussion draft, which did not mention such a pathway.
The agency also calls for publicizing notification information about IVDs, approaches to reviewing and modifying IVDs, and mechanisms to protect patients when FDA finds problems in IVDs. Finally, FDA calls for mechanisms to grandfather in or remove IVDs that are already on the market, as well as to ensure access to tests for small patient populations.
In their group letter to Congress, stakeholders said they are reviewing FDA’s proposal in order “to inform continued discussions with Congress and the Administration” in their efforts to encourage comprehensive reform in 2018.