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- FDA Hosts Webinar on IVD Classification July 16
On July 16 from 1:00 PM – 2:00 PM ET, the Food and Drug Administration (FDA) will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.
IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and post market controls. IVDs are generally also subject to categorization under CLIA.
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.
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 not be taken during the live webinar.
Registration is not necessary. Use this link to join the webinar: https://fda.zoomgov.com/j/1616994355?pwd=cWZhS2RucTU4ZUNLbGF5ZFN5Wlo5dz09
Passcode: %KeTf9
For more information visit: Webinar - In Vitro Diagnostic Product (IVD): Classification