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The U.S. Food and Drug Administration (FDA) is announcing a webinar regarding its proposed rule ”Medical Devices; Laboratory Developed Tests” (LDTs).
The purpose of this webinar is to provide an overview of the proposed rule to amend the FDA’s regulations to make explicit that in vitro diagnostics products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. The FDA will share information on the proposed amendment and phase out policy under which the FDA intends to provide greater oversight to help ensure the safety and effectiveness of LDTs.
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Webinar Date: Tuesday, October 31, 2023, from 1:00 PM – 2:00 PM ET
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Location: webcast
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Registration: Not required
Questions?
If you have questions about this proposed rule that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by October 23, 2023, 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.
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