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FDA Again Tries to Regulate LDTs: This Time It Will Work, Unless...
(Thursday, October 5, 2023) For the last 15 years, the FDA’s attempts to regulate Lab Developed diagnostic Tests (LDTs) were rebuffed due to the lack of political will for such regulation or public support. FDA unsuccessfully tried to get Congress to pass new LDT laws, and its proposed guidance documents to regulate LDTs were derailed by strong opposition from the industry. A 2020 directive from the Secretary of Health and Human Services (HHS) explicitly directed the FDA to create a new rule for LDTs rather than trying alternate ways to regulate LDTs. This week the FDA announced exactly that. Unlike its previous efforts, this process does not depend on Congress, and although it requires the FDA to collect public opinion about it, FDA can push the rule forward despite opposition from the industry. So, will the FDA succeed this time? Under the current regulatory paradigm, LDTs can be offered by CLIA-certified labs under prescription and do not require registration or clearance/approval from the FDA. Although the FDA repeatedly claimed over the years that it has jurisdiction over these in vitro diagnostic (IVD) tests under existing laws, LDTs have been subject to the FDA’s “enforcement discretion” for the last 30+ years. FDA allowed the LDTs to proliferate unchecked over these years. Audits of LDTs are rare and we could find only one FDA Warning Letter to a lab selling LDTs. Although there is no official count of how many LDTs are available, it is estimated by reliable sources that there are anywhere from 12,000 to 20,000 labs offering a total of more than 100,000 LDTs conducting at least tens of millions of tests every year. FDA’s primary complaint is that the LDTs have evolved from a few specialized tests offered by small local labs in the 1980s to tests offered to the masses by national labs that manufacture them in high volume for large and diverse populations. The LDTs of today look identical to the conventional IVDs that need to get cleared/approved through the 510k or PMA process, except LDTs do not get subjected to the same thorough review of validation of the accuracy and validation as those reviewed by the FDA. This is not only unfair to conventional 510k or PMA diagnostics but also allows scrupulous players to circumvent FDA reviews for dubious and poorly validated diagnostics. FDA cited several cases where the tests it rejected during regulatory reviews, ended up being offered as LDTs anyway. The CLIA-license requirements are not stringent enough to regulate LDTs, a fact exploited by labs offering LDTs. The FDA proposed a new rule that would require 510k or PMA approval for all LDTs. There would be a 4-year period during which the FDA will “phase out” the enforcement discretion for LDTs so by the end of the 4th year, all LDTs will be subjected to the same rules as the conventional IVDs. The 4-year phase-out period is intended to allow current LDT manufacturers to either file 510k or PMA applications with the FDA for evaluation of their tests or leave the market if they are unable to meet FDA’s requirements. This is the most stringent proposal by the FDA to regulate LDTs so far. It does not offer grandfathering of LDTs with significant history, nor does it allow any exceptions for LDT to be considered low risk and hence subject to Class I medical device requirements. The 83-page announcement for the new rule includes a detailed discussion of the history of this rule and claims wide legal authority to amend the current regulation to add provisions for LDTs. Obviously, the FDA anticipates legal challenges to the proposed rule and hence it has tried to provide lengthy legal justification for this rule. The document will be read carefully by the legal community to find holes in the FDA’s arguments and use them to challenge the proposed rule. It is also feasible that the FDA may have crafted such a stringent rule to give it room for negotiations with the affected industry. This rule, if and when, finalized would be one with the greatest impacts on the patients, testing labs, and the FDA. For the patients, it will remove several tests that the patients may have used for a significant period, creating uncertainty for the past diagnoses. For the industry, it would require the enormous tasks of creating 510k and/or PMA applications and pursuing them through the FDA. For the FDA, it would create a deluge of new market approval applications. Currently, the FDA clears a little more than 3000 510k applications every year. It is anybody’s guess what the FDA would do if it received 50,000 new 510k applications. The FDA would not be able to handle so many new 510k applications with its current staff. So, we are looking at another huge FDA growth in size and budget, and delays in market approval decisions. One thing is certain, we are in for an interesting 6–12-month period when the new LDT rule will be discussed, and a final outcome will emerge. For this is the FDA’s strongest and perhaps the final attempt to regulate LDTs. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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