On October 31, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar to provide information on the proposed rule regarding Laboratory Developed Tests or LDTs.
During the webinar, the FDA will:
- Provide an overview of the rulemaking proposal to amend the FDA’s regulations to make 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.
- Describe the proposed phaseout of FDA’s general enforcement discretion approach to LDTs.
- Host a Q&A session based on questions that have been submitted prior to the webinar at [email protected]. Questions will not be taken during the live webinar. All questions are due by October 23, 2023, to be considered for the discussion.
The webinar will take place on October 31 from 1-2PM ET.
