United States: FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply To Laboratory Developed Tests - Foley Hoag LLP

United States: FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply To Laboratory Developed Tests - Foley Hoag LLP

Mondaq

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The Food and Drug Administration's (FDA) proposed rule would change decades of Laboratory Developed Test (LDT) regulation by expressly considering these in vitro diagnostics (IVDs) medical devices.

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