Tens of thousands of medical tests to now fall under federal oversight

The Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests under the same jurisdiction as other testing, which the agency says will help ensure better safety and efficacy.

Since 1976, the FDA has not enforced legal requirements on most laboratory developed tests (LDT) due to the Medical Device Amendments. Generally speaking, this has meant that requirements like good manufacturing practices, premarket reviews prior to use in patients and adverse event reporting has not been enforced.