Laboratory Developed Tests (LDTs)
Agency Resources | NILA Advocacy | New Developments
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 LTDs: 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FDA Draft Guidance: Framework for Regulatory Oversight of LDTs
FDA Draft Guidance: Notification and Medical Device Reporting of LDTs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
S.2209 - VALID Act introduced June 24, 2021
S.1666 - VITAL Act introduced May 18, 2021
NILA Advocacy and Information
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