Can the FDA Prevent Medical Misdiagnoses?

While the FDA regulates drugs and medical devices for safety and efficacy, it does not have similar oversight for lab-developed tests.

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Lab tests are pivotal in patient care, and inaccurate results can lead to misdiagnosis. A recent opinion piece from The Washington Post discussed the necessity for FDA regulation of lab-developed medical tests to prevent misdiagnoses. While the FDA currently oversees drugs and medical devices, lab-developed tests lack similar oversight. The proposed FDA plan would require evidence of the tests' effectiveness and be phased in over a period of four years. 

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