Advocacy
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.
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FDA Draft Guidance: Framework for Regulatory Oversight of LDTs
FDA Draft Guidance: Notification and Medical Device Reporting of LDTs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
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
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