FDA proposes phased regulation of thousands of laboratory tests to improve accuracy and oversight

The FDA aims to regulate laboratory medical tests that have previously lacked oversight.
The proposed rule would gradually phase in FDA oversight over 5 years to ensure test safety, accuracy and reliability.
Inaccurate laboratory test results have led to concerns about incorrect diagnoses and inappropriate treatments.
The multibillion-dollar laboratory test industry has seen rapid growth in testing for complex diseases and conditions.
Regulation seeks to address issues like faulty cancer and heart disease tests that provide misleading results.