Since the passage of the Medical Device Amendments of 1976, the FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a comprehensive set of FDA requirements. Meanwhile, the FDA also asserted that it had the authority to regulate in-house tests developed and performed by CLIA-certified high-complexity clinical laboratories (usually referred to as laboratory-developed tests or LDTs), but chose as a matter of discretion not to regulate TDLs. Over time, the Agency has slowly reduced discretion in applying LDTs, removing certain types of tests (e.g., direct-to-consumer LDTs) and thus subjecting them to regulation, but generally has not taken no general measures to regulate LDTs.
The FDA’s approach changed in 2014 when it released draft guidance outlining a plan to phase out FDA enforcement discretion and regulate LDTs. The guidelines have created some controversy, raising concerns about statutory authority (some claiming that the FDA lacks the authority to regulate LDTs), process (with objections to changing a long-standing regulatory position date through guidance) and practicality (with concerns about how the FDA might handle an influx of liability on LDTs). The draft guidelines were withdrawn shortly before the start of the Trump administration.
However, interest in FDA regulation of LDTs continued to garner bipartisan support, particularly in the development of new statutory authority that would address concerns that the FDA guidance approach had created. After the introduction of legislation in previous Congresses that did not advance, the Senate recently attached the “Advanced IVCT Development Accurate Verification Act of 2022” (the “VALID Act”) to its first draft of user fee legislation “must pass”. . The bill will undergo majors over the next few days, potentially with hearings afterward, so it could be subject to change or scrapped entirely, but tying the language to the Senate HELP bill reflects a strong probability that the legislation, in some form, will become law.
Main provisions of the VALID law
Similar to previous versions, the fundamental feature of the VALID Act is the designation of a separate regulatory pathway for “in vitro clinical testing”, which is broadly defined to include both traditional IVDs and LTD. The VALID Act would impose requirements and authorities governing premarket review of tests, test registration and listing, test design and quality, labeling, adverse events, and corrections and deletions. It would also provide for post-market surveillance obligations and specify how a test can be considered adulterated or mislabeled for enforcement purposes.
The text of the VALID Act provides that once implemented, the new FDA regulations would follow in accordance with the development of standard notice and comment rules to implement the various components of the new regulatory regime. For example, specific quality system regulations would be defined for in vitro clinical test developers that will take into account existing CLIA regulations and cover topics such as management responsibilities, quality audit requirements, personnel, design, document checks, identification and traceability, production and process checks, non-conforming tests, corrective and preventive actions, labeling and packaging checks, complaints and records.
With respect to existing TDLs that have been subject to historical enforcement discretion, the VALID Act would allow exemptions for certain tests from premarket review requirements, including, in particular, grandfathered tests which were first proposed for clinical use by a laboratory before the date of promulgation. However, if the test is modified or if the FDA otherwise finds that there is insufficient supporting scientific evidence, that there are misleading or fraudulent claims regarding the test, or that there are a risk that the test will cause serious adverse health consequences, then the test’s exemption status could be revoked, thus subjecting it to the new regulations. Importantly, grandfathered tests must still comply with VALID Act registration requirements, and developers of existing in vitro clinical tests (including LDTs) would have one year from the date at which the registration system becomes available for compliance.
The VALID Act also includes a provision for the FDA to accredit individuals both for the purpose of reviewing premarket review applications once the VALID Act comes into effect and for the purpose of inspecting developers submitting these requests. The VALID Act would impose a 30-day time limit on the FDA to review recommendations made by any accredited person regarding a premarket application. This additional mechanism is likely an effort to mitigate the anticipated large volume of requests the FDA will receive.
All amendments under the VALID Act would become effective October 1, 2027, but certain sections (including registration and listing requirements, once the system is made available by the FDA) are permitted to begin implementation as of October 1, 2024. The language clarifies that any guidance or regulation issued under the Interim Amendments will not be implemented or come into force until the effective date of the VALID Act , which essentially allows for a transition period of at least five years.
If enacted, the VALID Act will take years to fully implement, but could have far-reaching implications for diagnostics development, and standards for diagnostic testing in US laboratory compliance functions will certainly need to evolve. and expand to navigate the addition of FDA requirements. In addition, legislative changes will create investment opportunities, as new FDA legislation of this magnitude often results in company closures and consolidations (for example, mergers between laboratories, or between laboratories and drug manufacturers). IVDs currently regulated by the FDA), as well as a growth of service industries that would support further regulatory efforts. Additionally, there could be strong growth opportunities for companies that can anticipate, effectively advocate for, and navigate the final regulatory path as it translates from law to FDA regulations and guidelines.
 As with most FDA statutes, powers are assigned to the Secretary of Health and Human Services, who in turn has standing policies to delegate federal food, drug, and cosmetic law responsibilities ( to which the VALID Act will be added) to the FDA. We assume that the Secretary will adopt a similar delegation approach here, although theoretically he could administer the law in a different way. A recent example of this occurred during the Trump administration, when the secretary rescinded FDA policies on Covid-19 LDTs that imposed premarket review requirements.
©2022 Epstein Becker & Green, PC All rights reserved.National Law Review, Volume XII, Number 140