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- Read FDA Responses to LDT Questions
The Food and Drug Administration (FDA) has posted its responses to the most commonly asked questions about its rule on laboratory-developed tests (LDTs). The questions were received through the FDA’s mailbox address, ldtfinalrule@fda.hhs.gov.
The FDA’s responses are on its FAQ page and here:
- Definitions and General Oversight
- Phaseout Policy and Enforcement Discretion Policies
- Labeling
- Premarket Review
- Investigational Use
- Specific Test Categories or Technologies
- Resources and Interactions with FDA
If you have a question about a specific test, the FDA suggests you contact the agency through the pre-submission process, which includes an opportunity for a meeting regarding such a test.