Friday, October 20, 2023

FDA Webinar on Big LDT Proposal: October 31, 1-2 Eastern (10-11 Pacific)

At the above, read about an FDA webinar on its "Regulation of LDTs" proposal.   The webinar will be one hour (at 10 pacific, 1 eastern) on Tuesday, October 31.   FDA will only answer questions it chooses to discuss, from questions in advance at a provided email by Monday, October 23.   The presentation will eventual be posted (info provided).

It looks like the link is an open Zoom link (no registration).


Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests

OCTOBER 31, 2023


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 Questions will not be taken during the live webinar. All questions are due by October 23, 2023, to be considered for the discussion.

Illustration: Dalle 3 via Chat GPT 4.0 subscription app.