October 18, 2021
Dear In Vitro Diagnostic Manufacturers,
The U.S. Food and Drug Administration (FDA) is reminding the diagnostic device industry that we require Institutional Review Board (IRB) review for all clinical investigations of devices 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. For further explanation, see the Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices 2018 final rule.
The 2006 FDA guidance, 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 FDA issued the guidance to help reduce obstacles for IVD device development and to facilitate development consistent with Good Clinical Practices (GCP) and Clinical Trials. However, the guidance expressly states that for those clinical investigations in which we intend to exercise enforcement discretion for informed consent, the requirement for IRB review in accordance with 21 CFR Part 56 remains.
Conformity with GCP 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.
For more information, including information about data from investigations conducted inside or outside of the United States, please see Good Clinical Practice Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic Device Premarket Submissions.
William Maisel, MD, MPH
Director, Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food and Drug Administration