Unpacking the FDA’s Proposed Rule for Laboratory Developed Tests

After years of discussion surrounding public confidence in the reliability of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) has put forth its own proposal that would upend current regulations by granting the agency oversight of LDTs. If enacted, the proposed rule would phase out the current enforcement discretion approach for LDTs and instead reclassify these tests as in vitro diagnostic (IVD) devices subject to lengthy and potentially costly FDA pre-market reviews.

Join us at 12:00 p.m. EST, Wednesday, Nov. 8, as we welcome attorney Gail H. Javitt of health law firm Hyman, Phelps, and McNamara, and “The FDA Law Blog”, to dive into the specifics of this proposal and how labs stand to be impacted. Although discussion surrounding this rule remains fluid as the FDA seeks additional input from labs and stakeholders, now is the time to ensure your lab understands how your ability to develop and offer LDTs could be affected.

We will review:

• How the current enforcement discretion approach for LDTs would change.
• A timeline for the rollout of the proposal’s five phases.
• Questions surrounding pre-market submissions and test complexity.
• How labs can offer public comments and input.
• Q&A