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FDA to Host Webinar on Proposed Rule for Laboratory Developed Tests

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The Food and Drug Administration (FDA) will hold a webinar at 10 a.m. (PT) on Oct. 31 to discuss its proposed rule for laboratory developed tests (LDTs).  

During the webinar, the FDA will: 

  • Provide an overview of the rulemaking proposal to amend its regulations to make explicit that in vitro diagnostic (IVDs) products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD product is a laboratory. 
  • Describe the proposed phaseout of its general enforcement discretion approach to LDT. 
  • Host a Q&A session based on questions that have been submitted prior to the webinar at Questions will not be taken during the live webinar. All questions are due by Oct. 23 to be considered for the discussion.