De-identified left over human specimens: not research with human subjects or FDA regulated research?

August 19, 2019

Activities involving de-identified human specimens that do not require IRB approval under the Common Rule Protection of Human Subjects regulation must still receive IRB approval if the activities are subject to U.S. Food and Drug Administration (FDA) regulations. The definition of a clinical investigation involving a medical device can include de-identified left over tissue if the focus is to develop diagnostic products including reagents and test kits or an algorithm for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]. When in doubt, check with the Compliance office.