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FDA Issues IVD Research, Investigational Use Draft Guidance

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has released a draft guidance outlining its recommended practices for using and marketing in vitro diagnostic tests for research and investigational uses only, and it has opened a public comment period on the document.

The recommendations are aimed at clarifying what types of IVD products are labeled "for research use only" (RUO) and "for investigational use only" (IUO), and how FDA thinks they should be used and marketed, but it does not provide requirements that are not already being enforced. The recommendations include language suggesting that FDA may want companies selling RUO/IUO IVDs to stop selling their tests to customers who may be using them inappropriately for clinical applications.

The guidance published yesterday covers tests that are in the lab research phase of development and tests that are being shipped for product testing prior to full commercial marketing. FDA said the guidance provides answers (developed by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research) to common questions about RUO/IUO marketing practices.

FDA said that it issued the guidance to remind makers of these tests how they are to be used and marketed and to clarify the RUO and IUO distinctions, which enable the sale of tests without FDA pre-market review, so long as they are not being sold for clinical use.

Such a move was necessary, FDA said, because in some cases unapproved IVD products have been marketed for use as clinical diagnostics, which could mislead health care providers and patients who do not know that they are to be used only for research or investigational purposes, and could lead to serious adverse health consequences for patients.

To meet the already established requirements for the RUO/IUO regulatory exemptions, these tests must be non-invasive, they must not require an invasive and risky sampling procedure, and they must not be used as a diagnostic without confirmation by another, medically established diagnostic test.

FDA said these tests may be studied for potential clinical clearance, but they also may be marketed before they are cleared so long as they are marketed only for uses directly involved in research and investigation.

As it reviews marketing practices, FDA will look in part at how the intended uses of the test are described in advertising or promotions. For example, inappropriate advertising for RUO/IUO tests would include claims or suggestions that they are to be used in a clinical investigation or for any clinical diagnostic use, or that clinical labs may validate these tests through their own investigations and then offer them for use as clinical diagnostics.

The guidance also states that if an IVD maker knows, or has reason to know, that its clinical lab customers are using its tests as a clinical diagnostic then it should halt its sales to that customer or comply with FDA's pre-market review requirements. FDA also said that manufacturers or distributors of these tests should not promote IVD components, instruments, or reagents labeled RUO/IUO for use in a lab-developed test that it knows is used in clinical diagnosis.

While the agency said that in some circumstances these test makers may include instructions for how their tests should be used, they should not include instructions for how they may be used for non-research purposes, or include discussion of clinical significance or other indications of clinical applications.

The guidance also states that software that is designed to serve as a stand-alone IVD product, or as an accessory to another IVD, may be marketed and sold for research and investigational use as long as it is in accordance with the already established rules for RUOs and IUOs.

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