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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 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 this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to LDTs.
Reminder: The FDA will host a webinar to provide information on how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 (Stage 1 of the phaseout policy).
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Webinar Date: Thursday, August 22, 2024, from 1:00 PM – 2:30 PM ET
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Location: webcast
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Registration: Not required
Questions?
If you have questions about this webinar, contact the Division of Industry and Consumer Education.
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