The US Food and Drug Administration (FDA) has released guidance that discusses how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study.
The new draft guidance on investigational IVD devices used in clinical investigations of therapeutic products is intended to inform stakeholders, including institutional review committees reviewing clinical investigations, and sponsors that therapeutic product trials that include investigational IVDs are subject to FDA’s investigational device exemption regulation, regardless of the source or manufacturer of the device, in addition to the investigational new drug regulation.
This guidance is intended to aid sponsors and institutional review committees in making decisions about the nature of risks of investigational IVDs used in therapeutic product studies to streamline the decision-making process. The guidance provides information about: definitions and concepts that are important in assessing investigational IVD risks; the roles and responsibilities of sponsors in complying with investigational device exemption requirements and FDA’s recommendations for submitting significant risk investigational IVD information in an investigational device exemption application.
To view the FDA guidance on investigational IVDs used in clinical investigations of therapeutic products, please click here.