Final Thoughts

Published: November 14, 2012
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CLIA-Waived Tests: Continuing the Conversation

There is a need to revisit whether the current regulatory scheme is the most appropriate approach to ensuring both the safety and effectiveness of POL IVDs and facilitating their availability and utilization.

By: Thomas M. Tsakeris

A two-tiered regulatory scheme currently imposed on sponsors of new point-of-care (POC) IVDs, particularly devices intended for the physician office laboratory (POL), was characterized as unduly burdensome in a column titled, “CLIA-Waived Tests: Is There Another Way?” published in the March/April 2010 issue of IVD Technology.
In brief, a prospective sponsor of a new POL test not only must secure FDA clearance but, in many cases for marketing reasons, also must obtain CLIA waiver for the test to be used, since most POL facilities are certified under CLIA to perform testing using only waived tests. Because of ongoing concerns among regulators about the quality of testing performed by POL operators such as nurses and physician assistants, who typically lack formal training in clinical laboratory testing, the level of validation testing required for 510(k) clearance and subsequently CLIA waiver are significantly higher than for other IVDs performed in a clinical laboratory. Few would deny the benefits of POC/POL IVDs in terms of rapid turnaround time of test results in settings proximal to patients, where patient management decisions can occur and be implemented almost immediately. Hence the need to revisit whether the current regulatory scheme is the most appropriate approach to ensuring both the safety and effectiveness of POL IVDs and facilitating their availability and utilization.
FDA’s approach to evaluating the safety and effectiveness of POL IVDs under device regulations is not fundamentally different from its approach to all other IVDs—to ensure that a given IVD performs acceptably in the intended-use environment. Thus, for POL IVDs FDA typically requires that test accuracy and reliability be assessed as part of “field” studies involving POL sites, where testing is performed by typical test operators. To address concerns about operator inexperience, FDA often requires test evaluation at a minimum of three different POL sites. FDA determination of test acceptability is based on a demonstration that the POL test is comparably accurate and reliable as a similar test intended for use in a clinical laboratory. Importantly, the consequence of FDA’s decision that a given POL test is “substantially equivalent” is that it is deemed suitable for use in less-controlled settings by inexperienced operators. However, as has been mentioned, obtaining FDA clearance to commercially distribute a test to a POL setting may not be sufficient unless the test has also been granted CLIA waiver by FDA. The current process requires that CLIA waiver evaluations be performed separately and subsequently to 510(k) clearance. CLIA waiver requirements are different than 510(k) clearance requirements, since the test not only must be shown to be accurate and reliable but also “simple” and “fail-safe.” To demonstrate the latter, FDA has disseminated guidance that prescribes not only the types of tests that are eligible for waiver consideration based on test simplicity aspects but also extensive reflex testing that demonstrates exceptional test robustness. The intent here is not to argue against the reasonableness of FDA’s CLIA waiver guidance, as many of FDA’s recommendations for testing a candidate test’s robustness are in fact reasonable. From a public health standpoint, however, the burden imposed on POL sponsors by this two-tiered regulatory path is arguably unreasonable. Considering all the merits of POL IVDs, the current regulatory scheme is as good an example as any of how burdensome regulation is contrary to public health. This is because more and more prospective POL IVD sponsors, which typically are small innovative IVD companies, simply do not have the resources to obtain both 510(k) clearance and CLIA waiver.
As mentioned in the earlier column, congressional action might be necessary to rectify the current situation. That is unlikely given the current state of congressional deadlock. A simple solution might be to merely revise the current CLIA waiver requirements by specifying that any test specifically intended for use in a POC or POL setting that is cleared or approved by FDA should be immediately available for use in such settings without restriction. Accordingly, FDA would be required to develop a Special Control for POC/POL IVDs in the form of a guidance document that might integrate aspects of FDA’s current 510(k) clearance criteria with its CLIA waiver guidance, such as requiring additional reflex testing to demonstrate test robustness, but eliminate the test simplicity criteria. Moreover, POC and POL IVDs would be evaluated under a single 510(k) submission, thus avoiding a multi-tiered regulatory path.

Thomas M. Tsakeris is president, Devices and Diagnostics Consulting Group (Rockville, MD). He can be reached at

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