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FDA's regulation of laboratory developed tests (LDTs) - changes on horizon?
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • June 30 2010

For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests ("LDTs") - those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes - as medical devices.

Deborah M. Shelton
  • Sheppard Mullin Richter & Hampton LLP