Inside Washington: What’s Going on with Regulation of LDTs?
Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here’s a rundown of the latest developments and what to expect going forward. From DAIA to VALID Impetus for LDT regulation was initially supplied by the FDA. But after a pair of flaccid draft proposals followed by the agency’s decision not to meet the December 2016 deadline for a final proposal, the epicenter shifted to Congress starting with a bi-partisan bill called the Diagnostic Accuracy and Innovation Act (DAIA) proposing to remove diagnostic tests from the definition of a medical device and thus not subject to the FDA’s 510(k) process for medical devices requiring test makers to compare their assays to predicate products approved in the 1980s. DAIA would instead establish a new system for regulating in vitro clinical tests (IVCTs). The FDA countered with a proposal that would keep LDTs within the 510(k) framework but modernize predicate device performance criteria and create an alternative 510(k) pre-certification pathway for certain “well-understood” product types. In response, the original sponsors of DAIA incorporated the FDA’s ideas, including the pre-certification program concept, into a new bill called the Verifying […]
Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here's a rundown of the latest developments and what to expect going forward.
From DAIA to VALID
Impetus for LDT regulation was initially supplied by the FDA. But after a pair of flaccid draft proposals followed by the agency's decision not to meet the December 2016 deadline for a final proposal, the epicenter shifted to Congress starting with a bi-partisan bill called the Diagnostic Accuracy and Innovation Act (DAIA) proposing to remove diagnostic tests from the definition of a medical device and thus not subject to the FDA's 510(k) process for medical devices requiring test makers to compare their assays to predicate products approved in the 1980s. DAIA would instead establish a new system for regulating in vitro clinical tests (IVCTs).
The FDA countered with a proposal that would keep LDTs within the 510(k) framework but modernize predicate device performance criteria and create an alternative 510(k) pre-certification pathway for certain "well-understood" product types.
In response, the original sponsors of DAIA incorporated the FDA's ideas, including the pre-certification program concept, into a new bill called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. Unlike DAIA, the VALID Act makes FDA's authority to regulate IVCTs, and therefore LDTs, explicit. The aim is to establish a framework for overseeing IVCT's at the FDA.
The lab industry had a mixed reaction to the new approach, signaling interest in the idea of a pre-certification process for IVCTs while expressing concern with the FDA proposal's lack of a clear timeline.
Takeaway: VALID 2, VALID 3, VALID 4, etc.
Meanwhile, it appears that the Congressional sponsors of the VALID Act are planning to propose an updated version of the legislation built around pre-certification process idea. But while consensus is building and progress is being made, there's still a lot of work to be done. Speaking at a recent conference, ACLA President Julie Khani suggested that VALID 2 may not be the last iteration of legislation and that working out the details of a pre-certification process for LDTs will be a multiyear process.
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