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FDA Webinar: Overview of In Vitro Diagnostic (IVD) Product Classification

Tuesday, Jul 16, 2024

U.S. Food and Drug Administration, Center for Devices and Radiological Health

The U.S. Food and Drug Administration (FDA) is hosting a webinar to review how in vitro diagnostic products (IVDs) are classified by the FDA.IVDs 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. The FDA classifies medical devices, including IVDs, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process.

View the Webinar Details

Questions? If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov

All questions must be received by June 28, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar.If you have questions about this webinar contact the Division of Industry and Consumer Education.