July 11, 2022
Legislation would combine diagnostic test categories while granting FDA authority to regulate both
Designed to enhance diagnostic test oversight, the Verifying Accurate Leading-edge IVCT Development Act of 2022 (the VALID Act) is a bipartisan bill that addresses a topic that has been discussed across the industry, legislative, and regulatory communities for years. Currently, the Centers for Medicaid and Medicare Services (CMS) oversee laboratory-developed tests (LDTs) on a federal level per the Clinical Laboratory Improvement Amendments (CLIA), while the Food and Drug Administration regulates in vitro diagnostic (IVD) test kits under the medical device framework.
There are many differences between the proposed regulation and the oversight currently provided by CLIA and FDA. For example, CLIA provides oversight of the analytical validation and performance of the test but does not regulate the clinical validity of a test. If enacted, the VALID Act would create a new category of in vitro clinical tests (IVCTs) that includes IVD test kits and LDTs. This would newly direct the FDA to regulate LDTs and modify FDA's current approach to regulating IVDs.
The VALID Act is attached to the FDA user fee package of the draft FDA Safety and Landmark Advancements (FDASLA) Act, which was approved by the Senate Health, Education, Labor and Pensions Committee on June 14, 2022. Although the VALID Act is not yet law, its attachment to the Senate version of the FDA user fee package in the FDASLA Act suggests that some form of it may be enacted.
Implementation of VALID would create major changes in the industry. VALID would create a risk-based framework for IVCTs, requiring high-risk tests to go through premarket review while enabling lower-risk tests to go to market after passing "technology certification." A major difference is that technology certification would allow IVD developers to submit one representative test for FDA approval, rather than the current framework where each new assay or indication is considered individually. If FDA agrees with the design and clinical validity of the representative test, the developer would have a less burdensome path to market for subsequent tests using the same technology. Technology certification would be a significant change in the way tests are currently regulated. LDTs would be subject to the same framework, although VALID would "grandfather in" those currently in use.
Other VALID changes would likely include new requirements regarding:
- Registration and listing of the tests, including the registration of all LDTs even if they are exempt from premarket review.
- Test design and quality, labeling, adverse events, and corrections and removals.
- Post-market surveillance obligations.
- User fees to fund the review of IVCTs developed by commercial test developers as well as individual, nonprofit laboratories.
FDA regulation of LDTs has historically been a source of controversy, with some groups, such as FDA regulators, seeking additional control over LDTs compared to the oversight provided by CMS and other groups lobbying to maintain the status quo. LDTs might successfully fall under FDA regulation now thanks to the push offered by current public opinion in response to high-profile LDT quality issues. For example, in April the FDA issued a warning about the risks of false results with genetic non-invasive prenatal tests in response to complaints they received.
The COVID-19 pandemic also seems to have influenced the role of regulation in LDTs, as LDTs seeking Emergency Use Authorization (EUA) fell under FDA's purview at the beginning of the pandemic. For example, back in October 2020, the director of FDA's then-Center of In Vitro Diagnostics and Radiological Health published an article indicating that in 125 EUA submissions by laboratories that had developed their own COVID-19 tests (LDTs), FDA identified design or validation issues in 82 of them. In the majority of cases, the issues were similar to those encountered by non-laboratory developers (IVDs), and FDA was able to work with the laboratories to correct the problem and allow the test to go to market.
Some groups have expressed concerns that the expense of user fees and time-consuming new technology certification processes and adverse-event reporting requirements may reduce patient access to testing. Similar concerns have been raised during previous attempts to regulate LDTs through FDA.
If enacted, the effective date for all amendments under the VALID Act would be October 1, 2027, but certain sections, such as registration and listing requirements, could be implemented as early as October 1, 2024.
How Exponent Can Help
Exponent's multidisciplinary team of biomedical science and engineering professionals provides support throughout the total product life cycle, specializing in regulated products and processes. Exponent offers deep technical capabilities related to assay and instrument development, including assay design, materials compatibility, artificial intelligence, machine learning, electromechanical design, optics and fluidics, combined with regulatory insights. With expertise in global IVD regulations, CLIA compliance, Software as a Medical Device regulations, quality system establishment, and FDA assessments, Exponent can assist in reviewing submission packages, auditing labs, or performing due diligence and validation/technical design of the assay, instrument, or collection kits. Our offerings also include reviewing diagnostic data to assess the completeness of the package for submission for many submission types including technical dossiers, EUA, PMA, 510(k), and De Novo submissions.