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- FDA LDT Phaseout Policy Resources and Upcoming Agency Webinars
The Food and Drug Administration (FDA) presented an overview of its laboratory-developed tests (LDT) final rule and answered several questions on May 14. The FDA responded to two questions submitted by the CAP regarding tests for unmet needs and oversight requirements for LDTs developed prior to the FDA rule.
If you missed the presentation, the FDA provided printable slides. In the coming weeks, the presentation, recording, and transcript will be available at CDRH (Center for Devices and Radiological Health) Learn under the "In Vitro Diagnostics" tab.
The FDA also announced it intends to hold additional webinars focusing on specific topics related to the phaseout policy.
- June 5, 2024: Draft Guidances on Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 (applicable to LDTs) and Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency (applicable to IVDs) Register here.
- July 2024: Tentative topic: IVD Classification
- August 2024: Tentative topic: MDRs (Medical Device Reporting), Quality System Complaint Requirements, and Recalls
To submit questions to be answered during the webinars, email CDRHWebinars@fda.hhs.gov at least one week prior to the webinar.
Additional resources can be found here: Laboratory Developed Tests. If you have questions for the FDA about the final rule, you can contact LDTFinalRule@fda.hhs.gov.