Get your free whitepaper: 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.

You’ll learn:

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