Center for Science in the Public Interest: FDA Finalizes Much-Needed Rule to Regulate Laboratory-Developed Tests
April 30, 2024
April 30, 2024
WASHINGTON, April 30 -- The Center for Science in the Public Interest issued the following news release on April 29, 2024:
In a critical step forward, FDA's rule closes a longstanding regulatory loophole
CSPI applauds the Food and Drug Administration's final rule regulating laboratory-developed tests (https://public-inspection.federalregister.gov/2024-08935.pdf) (LDTs) published today. LDTs, a subset of in-vitro diagnostic tests, are commonly used by patients and health . . .
In a critical step forward, FDA's rule closes a longstanding regulatory loophole
CSPI applauds the Food and Drug Administration's final rule regulating laboratory-developed tests (https://public-inspection.federalregister.gov/2024-08935.pdf) (LDTs) published today. LDTs, a subset of in-vitro diagnostic tests, are commonly used by patients and health . . .