Proposed Rule: Medical Devices; Laboratory Developed Tests

Tuesday, October 31 | 1 p.m. ET | Online

The U.S. Food and Drug Administration (FDA) will host a public webinar to provide information on the proposed rule regarding Laboratory Developed Tests (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 CDRHWebinars@fda.hhs.gov. Questions will not be taken during the live webinar. All questions are due by October 23, 2023, to be considered for the discussion.

Registration is not required. To learn more and access the Zoom webinar details, visit the event page.