FDA Webinar to Focus on LDT Proposed Rule

AABB encourages members of the blood and biotherapies community to attend an upcoming Food and Drug Administration webinar that will provide information on the agency’s proposed rule regarding laboratory-developed tests (LDTs).  

In the program, agency representatives 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. The webinar will also describe the proposed phaseout of FDA’s general enforcement discretion approach to LDTs. Additionally, FDA representatives will answer questions submitted prior to the webinar.  

The program will take place on Zoom from 1 to 2 p.m. ET on Tuesday, Oct. 31. Instructions to join the webinar are available online.