FDA's Regulation of Laboratory Developed Tests

For many years FDA has claimed the authority to regulate Laboratory Developed Tests, that is tests that are designed, produced, and used in a single lab – never being put up for sale. This authority, however, has been contested, and the FDA itself has traditionally practiced “discretionary enforcement,” wherein it has regulated LDTs very little. A change occurred in October 2023 when the FDA issued a notice of proposed rulemaking wherein it indicated its intention to codify its claim of authorit

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