 
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule amending the FDA's regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with that amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to laboratory developed tests (LDTs). FDA expects compliance with labeling requirements for most IVDs offered as LDTs by May 6, 2025 (Stage 2 of the phaseout policy).
The U.S. Food and Drug Administration (FDA) is announcing a webinar to provide information on how to comply with labeling requirements for IVDs including LDTs. These requirements help ensure that IVD labeling has a consistent set of information critical to understanding the IVD. The focus of this webinar will be on labeling requirements for test systems, under 21 CFR 809.10(b) and will not cover labeling requirements for other types of IVDs such as collection devices and general purpose reagents.
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Webinar Date: Tuesday, September 24, 2024, from 1:00 PM – 2:00 PM ET
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Location: webcast
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Registration: Not required
We anticipate high attendance for this webinar and there is limited capacity. However, due to the limited capacity we intend to post a recording and transcript as soon as possible following the webinar. We encourage you to dial in 15 minutes before the start of the call to allow time to connect.
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 August 23, 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.
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