May 14, 2024 Webinar: Final Rule for LDTs

Lab Issues & Questions 1 reply 27 views

Date: May 14, 2024
Time: 1:00 PM - 2:00 PM ET

On May 14th the FDA is hosting a Webinar regarding the final rule for medical devices and laboratory developed tests. During this webinar they will be describing the phaseout of the FDA's general enforcement discretion approach to laboratory developed tests (LDTs). For more information click the link to go directly to the FDA website.

During the webinar, the FDA will:

Provide an overview of the final rule amending the FDA's regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory; and
Describe the phaseout of the FDA's general enforcement discretion approach to laboratory developed tests (LDTs).

https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024

 

 

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