Tell the FDA that Laboratory-Developed Tests Should Not Be Regulated as Devices!

Laboratory-developed tests (LDTs) are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, and companion diagnostics. LDTs are vital tools for personalized medicine because labs can even create custom diagnostic tests.

Other diagnostic tests—in vitro diagnostic (IVD) test kits—are regulated by the FDA as “devices.” Commonly, these are products containing all or most of the components needed to perform a test, which are then packaged and commercially distributed. The FDA is considering whether to regulate LDTs the same way, which would mean each test would have an evidentiary mountain to climb—difficult when tests are custom-designed for one particular patient!

Tell FDA that regulating LDTs as devices is a bad idea.


  • Food and Drug Administration (FDA)


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Dear [Decision Maker],

[Your Name]
[Your Address]
[City, State ZIP]