> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Patient and Industry Groups Seek Diagnostics Reforms
- URL: https://www.fdaweb.com/patient-and-industry-groups-seek-diagnostics-reforms/
- Published: 2018-05-11T12:00:00.000Z
- Updated: 2026-09-15T00:04:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141418

A group of patient and industry organizations has written Congressional leaders urging them to enact legislation to “modernize the statutory oversight of clinical laboratory diagnostics, including laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).” The [5/9 letter ](https://dx.advamed.org/sites/dx.advamed.org/files/resource/dx%5Freform%5Fletter.pdf?ref=fdaweb.com)noted that FDA is currently reviewing an amended discussion draft of legislation being considered. “FDA commissioner **Scott Gottlieb** has made repeated public comments that comprehensive legislative reform of clinical laboratory diagnostics is timely and appropriate,” the letter says. “Additionally, as demonstrated by the breadth and diversity of the signatories on this letter, the recognition of the need for diagnostics reform has only grown among stakeholders. Therefore, we the undersigned, believe the time has arrived to enact a new statutory oversight framework to unleash diagnostic innovation and improve the quality of care available to patients.”