FDA says IRB review still needed for IVD studies involving human specimens

Regulatory NewsRegulatory News | 19 October 2021 |  By 

The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, "deidentified" human specimens still have to be approved by Institutional Review Boards (IRBs).
This pronouncement was made in an 18 October reminder letter to IVD manufacturers by William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within FDA’s Center for Devices and Radiological Health.
The IRB approval requirement applies to investigations using leftover deidentified human specimens  supporting an investigational device exemption, a marketing application, and to IVD technical or analytical studies that use human specimens.
FDA reiterated that its 2006 guidance on informed consent for IVD studies made clear that use of leftover human specimens that are not individually identifiable does not exempt such investigations from IRB reviews. Where FDA did state intent to exercise enforcement discretion in the guidance was with regard to informed consent requirements for these specimens under certain circumstances that are laid out in the document.
FDA issued the 2006 guidance “to help reduce obstacles for IVD device development and to facilitate development consistent with its guidance on Good Clinical Practices and clinical trials,” according to Maisel’s letter.
Leftover human specimens are defined in the guidance as “remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded.”
“Conformity with [Good Clinical Practices] is important and required for all clinical investigations, including investigations of IVD devices, to help ensure the data and results from clinical investigations are credible and accurate, and the rights, safety, and wellbeing of human subjects are adequately protected,” wrote Maisel.
For more information, manufacturers should consult FDA’s 2018 final rule on human subject protection and FDA’s requirements for data from clinical investigations for medical devices.
FDA letter


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Tags: FDA, IRBs, IVDs

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