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. 


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FDA Draft Guidance: Framework for Regulatory Oversight of LDTs

FDA Draft Guidance: Notification and Medical Device Reporting of LDTs 


New Developments

August 23, 2021
NILA Comments on the VALID Act of 2021 (H.R.4128/S.2209)

June 24, 2021
Reintroduced "VALID Act" Would Give FDA Explicit Authority to Regulate LDT's


NILA Advocacy and Information

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

January, 2017
FDA Releases Discussion Paper on Oversight of LDTs

April 2016
Sign On Letter from NILA and Other Laboratory Associations to House Appropriations Subcommittee

October 2015
NILA and 7 Other Health Care Organizations Forward Letter To Senate and House Regarding CLIA Modernization and Oversight of LDTs

June 2015
AAB/NILA Comments to the House Energy and Commerce Committee

February 2015
AAB/NILA Comments to the Senate Health, Education, Labor and Pensions Committee