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 authority and begin enforcing oversight of LDTs. Dr. Joel Zinberg, M.D., J.D., joined us to discuss the history the FDA’s regulation of LDTs, the proposed rule, and what the ramifications may be. * * * * As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.