BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with in vitro diagnostic (IVD) products; from ideation, pre-clinical work, full development, and preparation of a 510K submission leading to successful registration.
The U.S. FDA defines an IVD product as a reagent, instrument, or system intended for use in the diagnosis of a disease or other condition, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. IVD products are considered medical devices and are regulated by the Center for Devices and Radiological Health (CDRH). Three classifications of devices along with general registration requirements are discussed with examples of specific IVD products given for each classification. The Clinical Laboratory Improvement Amendment (CLIA) requirements for IVDs are also discussed.
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