Your Guide to the Verifying Accurate Leading-edge IVCT Development (VALID) Act
For more than four years, members of both houses of Congress have solicited input from a variety of stakeholders to improve Food and Drug Administration (FDA) oversight of Laboratory-Developed Tests (LDTs). The result is the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bi-partisan and bi-cameral bill designed to empower the FDA to regulate diagnostic tests. While the bill has not been passed yet, it is likely that it will move forward in some form and eventually become law.
This guide will help your IVD product team understand the provisions and implications of the VALID Act and how it applies to product development and risk management for medical devices.
Editor’s Note: As of the date of publication, the bill has not made it into FDA’s budget, but tighter regulations may be coming regardless.
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The FDA first received authority to regulate in vitro devices in 1976 under amendments to the Food, Drug, and Cosmetic (FD&C) Act. Following passage of those amendments, the FDA chose to exercise discretionary oversight over commercializing LDTs, citing the conclusion that LDTs were normally used within restricted environments for the benefit of the institution’s clinicians only.
Under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, the Centers for Medicare and Medicaid Services (CMS) was charged with setting performance standards for test validation and certifying qualified laboratories. Included for regulatory oversight under CLIA were LDTs, which are sometimes called “home brew tests” due to their design and use within a single lab.
The FDA started to move toward regulation of LDTs in 2010, and pharmaceutical companies, professional societies, and industry groups began to submit feedback for and against regulatory oversight. Guidance documents, discussion, and
early draft versions of regulatory legislation were ongoing until 2018, when the first version of the VALID Act was introduced in the House of Representatives.
The VALID Act is designed with the goal of modernizing regulatory processes for in vitro diagnostics (IVDs) and LDTs and clarifying the FDA’s authority to regulate LDTs. The act’s authors and contributors also hope to address discrepancies between the market pathway of LDTs and other FDA-cleared or -approved tests.
A recent Senate version of the bill is attached to a larger legislative package that reauthorizes the Medical Device User Fee Amendments (MDUFA), which expired at the end of September 2022.
Current versions of the VALID Act include the following provisions:
- Create a new category of IVD called “in vitro clinical tests,” or IVCTs. This category would apply to both commercial test kits and LDTs.
- Exempt existing LDTs from FDA pre-market review UNLESS they pose a safety risk for patients or are significantly modified after the act goes into effect.
- Create a risk-based system for the FDA to oversee LDTs. This system would classify LDTs as low-, moderate-, or high-risk.
- Provide measures to move LDTs into lower tiers of regulation. These measures include appropriate labeling, performance testing, submission of clinical data, clinical studies, and posting information to a website.
- Offer exemptions from FDA pre-market review for low-risk LDTs, low-volume tests, modified tests, manual interpretation tests, and humanitarian tests.
- Prohibit the FDA from infringing on the practice of medicine.
- Direct the FDA not to duplicate regulations that are already included in CLIA.
- Require the FDA to hold public hearings on LDT oversight.
- Create a process to establish user fees through negotiations between the FDA and the industry. Fees would be subject to congressional approval.
The VALID Act would be effective five years after the date of passage.
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While the VALID Act does have bi-partisan support in Congress, debate is ongoing within the IVD industry, and experts in professional societies and impacted companies continue to submit feedback and suggest improvements to Congress.
Opinions range from support for the current version of the VALID Act with zero to few modifications to creating more CLIA-centric options for regulations under a 2015 modernization proposal. In addition, there is concern among some interested parties that the VALID Act is adding more complexity than necessary when the act would complement existing CLIA guidelines.
As debate continues, both sides offer opinions about the pros and cons of the act:
- Closes a “gap” in regulatory oversight that allowed companies such as Theranos and Laboratory Corporation of America to market LDTs that never work or are prone to error. The VALID Act would ensure consistency in quality and performance standards.
- Updates and modernizes oversight of LDTs that was originally established in 1976 when such tests were much simpler and usually designed for small patient populations in a localized environment.
- Reorients focus to test effectiveness and accuracy and patient safety rather than where it is developed and used. Currently, even high-risk tests need not undergo external review, and there is no requirement to report adverse events from inaccurate results.
- Establishes a mechanism to track LDTs — how many there are, what they are used for, their level of complexity, etc.
- Includes provision to bring tests to market quickly under Emergency Use Authorization (EUA).
- Grandfathers almost all existing LDTs, and risk-based classification would allow some LDTs to be exempted from pre-market review process.
- Introduces a regulatory innovation—“technology certification”—that allows IVD developers to submit one representative test for FDA approval rather than each new assay or indication. This
- innovation would only apply to lower risk LDTs.
- Potentially places greater burden on FDA in the case of a high volume of EUA requests, as evidenced by a rush of requests to approve COVID-19 tests during the early days of the pandemic.
- Requires registration and listing of all tests, even if they aren’t subject to pre-market review.
- Imposes additional costs and regulations that could impede innovation and slow or halt life-saving research conducted in academic, clinical, and hospital labs.
- Remains unclear about what LDTs will be grandfathered and what constitutes a “significant modification” to an existing LDT that would require it to undergo premarket review.
- Duplicates existing regulatory oversight already being conducted by CMS under CLIA; laboratories in hospital settings already adhere to multiple accreditation and certification requirements.
- Could create an incentive not to update or improve existing LDTs because of the burden of regulatory review.
- Places burden of additional user fees on labs that already bear costs of registration and accreditation under CLIA and incur costs of onsite inspections and proficiency testing. These additional fees could drive some labs out of business, thereby stifling innovation and slowing patient access to care.
Despite the ongoing debate, most of the parties involved do agree that some modernization and reform is overdue in the IVD industry. Current rules were written decades ago and do not allow for modern technology, and the debate over regulation of LDTs has been going on for some time. In addition, recent events such as the Theranos fraud revelations, the COVID-19 pandemic, and concerns about pre-natal misdiagnoses due to ineffective testing have highlighted the concerns around testing accuracy and government efficiency. If reforms could help ensure better, more accurate tests and a more streamlined process for approval without higher burdens on laboratories, many industry concerns could be alleviated.