Laboratory Developed Tests (LDTs)/VALID Act
Agency Resources | NILA Advocacy | New Developments
Fact Sheet
Learn more about laboratory developed tests (LDTs) - NILA Fact Sheet on LDTs (pdf).
NILA Advocacy and Information
May 31, 2025
No Appeal of FDA/LDT Lawsuit Decision!
April 3, 2025
Summary of Court Decision Nullifying FDA Regulations for LDTs
April 1, 2025
FDA's LDT Regulations Struck Down by Texas Court
October 8, 2024
NILA and AAB File an Amicus Brief in Support of the ACLA and AMP Lawsuit Against FDA’s LDT Rule
April 29, 2024
NILA and American Association of Bioanalysts (AAB) Respond to FDA's Release of Final Rule on LDTs
December 5, 2023
NILA and AAB Comment on FDA’s Proposed LDT Rule
October 12, 2023
NILA and AAB Request Extension to Deadline for Comments on LDT Proposed Rules
October 3, 2023
FDA Announces Proposed Rules Regulating LDTs
September 19, 2023
NILA Urges OMB to Reconsider FDA's Proposed Rules Regulating LDTs
April 27, 2023
VALID Act Re-Introduced in House of Representatives<
December 9, 2022
NILA Urges House/Senate Leaders to Exclude VALID Act from Year-end Legislation
December 8, 2022
NILA Releases Updated VALID Act Talking Points
May 23, 2022
NILA Comments on Discussion Draft of VALID Act released May 17, 2022
March 2, 2022
NILA Sign on to Letter to House, Senate Committees Requesting a Full Hearing for LDT Oversight Regulation
Laboratory-Developed Tests (LDTs) offer patients the potential for preventing disease, obtaining early diagnoses, and receiving the most accurate and best course of treatment from their health care providers. Any regulatory process to oversee LDTs must appreciate the promise these tests hold without stifling innovation, while simultaneously ensuring patient safety and the accuracy, reliability, and reproducibility of LDTs. Two bills are before Congress to regulate LDTs: the VALID Act (FDA oversight) and the VITAL Act (CLIA oversight).
Agency Resources
FDA LDT Homepage
Access background information, notices about public meetings, and archived webinars
Legislation
H.R. 2369—VALID Act, introduced in the House of Representatives on March 29, 2023.