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

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

March, 2020
COVID-19 Public Health Reporting for Laboratories that Develop or Use Laboratory Developed Tests with Intent to Obtain EUA

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FDA Draft Guidance: Framework for Regulatory Oversight of LDTs

FDA Draft Guidance: Notification and Medical Device Reporting of LDTs 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

S.2209 - VALID Act introduced June 24, 2021

S.1666 - VITAL Act introduced May 18, 2021