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Laboratory Developed Tests: Issues and Anticipated Regulations

Learn the basics of LDTs along with current and potential regulations

In 2014, the FDA shifted its oversight framework from manufacturer type to one based on risk to patients. Since then, the Agency has gradually implemented this risk-based approach over the following years.

This guide gives a simple overview of laboratory developed tests, the current regulations they’re bound to, and what we know about anticipated LDT regulations.

What you'll find inside:

• An introduction to LDTs
• Common issues with LDTs
• Current regulations for LDTs
• Anticipated regulations for LDTs