The New Guidance on LDTs: A Q&A with the FDA


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If your laboratory performs LDTs, you need to register for this essential 60-minute webinar and learn how the new draft guidance could potentially affect molecular testing and other cutting edge tests. Dr. Alberto Gutierrez will outline what data labs will need under the draft guidance document to provide for new and existing LDTs and will describe what constitutes a modification to an LDT and what the agency will require when modifications are made. You will also learn draft guidance requirements for the data necessary for registering and listing an LDT, what constitutes an adverse event when performing an LDT and the laboratory's responsibilities for reporting it. Additionally, you will know what LDTs may be subject to lesser oversight and how the agency plans to phase-in periods for compliance.