The updated, bipartisan Verifying Accurate, Leading-edge IVCT Development Act (VALID Act), creates a regulatory framework for a new product paradigm called in vitro clinical tests (IVCTs), which would cover tests used in clinical evaluation of patients, including both laboratory developed tests (LDTs) and traditional in vitro diagnostics (IVDs) assays, as well as collection devices and instruments used with such tests. The bill is largely similar to the draft legislation released in 2018, although there are some notable differences.
Introduced into the House on 5 March 2020 by U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon, M.D. (R-IN), the VALID Act, having been in discussion draft for more than a year, recently gained momentum in Congress due to the urgent public health threat posed by the novel coronavirus. The bill’s authors contend that the new legislation would improve test development and mitigate test shortages during a public health crisis by, among other things, amending the emergency use authorization provision of the Food Drug and Cosmetic Act to include IVCTs. An identical version of the bill was also introduced into the Senate, sponsored by U.S. Sens. Michael Bennet (D-CO), and Richard Burr (R-NC).
According to the bill’s authors, the VALID Act “would establish a risk-based approach to IVCT regulation, prioritizing FDA resources for the highest-risk level tests that expose patients to serious or irreversible harms.” Under the VALID Act, IVCTs would constitute a new medical product regulated separately from drugs, devices, and biologics. The VALID Act does not create a new center within FDA dedicated to regulating IVCTs, and it is possible that oversight could fall to the Center for Devices and Radiological Health (CDRH). The bill would also bring an end to the longstanding controversies surrounding FDA’s regulation of LDTs by granting the agency oversight. The proposed legislation would apply elements of the medical device quality system requirements to clinical laboratories (such as design control and record keeping), but pointedly seeks to avoid duplication of regulations under section 353 of the Public Health Service Act. As such, there remains a risk of different standards being applied to the manufacture and propagation of the products between CLIA high complexity laboratories and manufacturers of distributed in vitro diagnostic products.
The legislation creates a risk-based framework for IVCT regulation. High-risk tests, such as novel tests, would be required to undergo premarket review to verify analytical and clinical validity. The VALID Act also creates a process for “technology certification” review, which allows IVD developers to submit a representative test for approval to FDA. FDA’s approval of the scope of the test – test design processes and procedures and clinical and non-clinical data – can then be applied to subsequent tests within the same scope, without necessitating further agency review. In the 2018 discussion draft, this process was referred to as a “precertification” tool for families of tests; and the new proposal appears to be mostly a change in terminology.
The VALID Act would exempt certain types of IVCTs from FDA review, such as for grandfathered tests, low-risk tests, tests for rare diseases, tests used for public health surveillance programs, forensic tests, and tests used for law enforcement and employer testing that are not used to make clinical decisions for individual patients. In addition, the Act permits IVCTs to be developed and used under an emergency use authorization during public health crises. The legislation details the premarket review and approval process FDA would be able to apply both to IVD manufacturers and to LDT developers who are currently subject to CLIA requirements. The legislation also specifies types of modifications that can be made to tests without additional FDA review.
The VALID Act takes a test systems approach to directly regulate many components and parts through premarket requirements (e.g., test platforms, software, test instruments, etc.), and the applicable standard for premarket review applied depending on the type of component or part. After an IVCT is approved, the VALID Act requires prompt reporting of serious adverse events and quarterly reporting of other individual adverse events. It also gives FDA broad authority to require post-market studies.
The comprehensive bill also establishes a breakthrough pathway to incentivize development of tests for patients with unmet medical needs, and includes provisions for investigational use, test design and quality requirements, listing and registration, and administrative enforcement. The legislation contemplates a four-year transition plan after enactment.
While the current VALID Act closely tracks the 2018 discussion draft there are some notable changes that stakeholders should be aware of. For example, the definition of “high risk,” which is based on the likelihood of serious harm following an inaccurate test result, appears to have been broadened. The 2018 discussion draft clarified that the likelihood for serious harm needed to be present when the IVCT was used as intended. This caveat is not included in the 2020 bill definition for high risk, thus expanding the definition. In addition, the 2018 draft stated that a test was “high risk” if an inaccurate result from the test would likely cause serious harm. This clause has been changed so that a test is high risk if an inaccurate result from the test presents potential unreasonable risk for serious harm, which is a broader definition.
We will continue to monitor the progress of the VALID Act and regulation related to in vitro diagnostics. Please contact us if you have any questions.
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