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Allied Organizations Call re FDA LDT Final Rule

Join LAB and the Association for Molecular Pathology on Tuesday, May 7, at 1 p.m. (EST) for a conversation about the FDA's LDT Final Rule to regulate LDTs as medical devices.

This rule will impact patients' access to innovative tests, lab operations, and pathologists' ability to practice medicine. Below is an overview of what will be discussed:

  • LDT Rule Overview

  • IVD Definition

  • Four-Year Phase In

  • Continued “Enforcement Discretion”

  • LAB Comments

  • AMP & other Allied Organization Comments

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

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February General Meeting

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May 30

Coalition Summer Meeting