Laboratory Developed Tests

On May 6, 2024, the FDA issued a final rule amending the definition of “in vitro diagnostic products” in 21 CFR 809.3(a) to add the words “including when the manufacturer of these products is a laboratory.” On March 31, 2025, a federal district court vacated that final rule. On September 19, 2025, the FDA issued a final rule reverting to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.

Historical LDT Related Links

• Medical Devices: Laboratory Developed Tests - Final Rule (vacated) (May 6, 2024)
• FDA and CMS Issue Joint Statement on LDTs (January 18, 2024)
• Proposed Rule: Medical Devices; Laboratory Tests (October 3, 2023)
• FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests (September 29, 2023)
• Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication (April 19, 2022)
• Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies - The real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) (November 16, 2015)
• Public Workshop - Oversight of Laboratory Developed Tests (July 19-20, 2010)
• Blueprint for Breakthrough - Charting the Course for Precision Medicine (September 13, 2018)
• FDA Discussion Paper on Laboratory Developed Tests (LDTs) (PDF - 180KB) (January 13, 2017)

Contact Us

For general regulatory information, please contact the Division of Industry and Consumer Education (DICE) by phone at:(800) 638-2041 or (301) 796-7100 or by email at: DICE@fda.hhs.gov.