FDA Webinar to Focus on LDT Compliance Requirements Following LDT Final Rule

The Food and Drug Administration will host a webinar on Aug. 22 to discuss how manufacturers of laboratory-developed tests (LDTs) can comply with regulatory reporting requirements as the agency implements its final rule that regulates LDTs as medical devices.

The webinar, scheduled for 1-2:30 p.m. ET, will address medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files. LDTs will be required to meet these requirements by May 6, 2025. Interested individuals can submit questions via email by July 22, 2024. The agency will not take questions during the live webinar.

FDA announced the four-year phase out policy in a May 6, 2024, final rule that amended the agency’s regulations to make explicit that LDTs are devices under the Federal Food, Drug, and Cosmetic Act.