Laboratory Developed Tests (LDTs)
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
September 19, 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
August 23, 2021
NILA Comments on the VALID Act of 2021 (H.R.4128/S.2209)
October, 2020
NILA Questions FDA Decision to Suspend EUAs for COVID-19 LDTs
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FDA Draft Guidance: Framework for Regulatory Oversight of LDTs
FDA Draft Guidance: Notification and Medical Device Reporting of LDTs