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

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

FDA Draft Guidance: Framework for Regulatory Oversight of LDTs

FDA Draft Guidance: Notification and Medical Device Reporting of LDTs 

Legislation

H.R. 2369—VALID Act, introduced in the House of Representatives on March 29, 2023.