IRB Review Needed for all IVD Studies: FDA

FDA is reminding in vitro diagnostic manufacturers that the agency requires an institutional review board (IRB) review for all device clinical investigations that involve human subjects, including those that use leftover, deidentified human specimens in FDA-regulated studies. “This requirement pertains to data used to support an investigational device exemption, device marketing application, or submission to the FDA, including in vitro diagnostic (IVD) technical or analytical studies that use human specimens,” the agency says in a 10/18 letter to industry.

The letter advises manufacturers review the following final rule for further explanation: Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices. It also notes that the 2006 Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable does not exempt any investigations from IRB requirements. “The guidance states that we intend to exercise enforcement discretion with regard to the requirements for informed consent under the circumstances described in Section IV of the guidance,” the agency says.