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# Lab Group Seeks Congress’ Help on LDT Rule
- URL: https://www.fdaweb.com/lab-group-seeks-congress-help-on-ldt-rule/
- Published: 2024-09-09T12:00:00.000Z
- Updated: 2026-09-14T14:40:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157738

The Association for Diagnostics and Laboratory Medicine (ADLM) is voicing significant concerns regarding the recent FDA final rule on laboratory developed tests (LDTs), and it is urging Congress to intervene while judicial reviews determine the agency’s authority to regulate LDTs. ADLM also urges Capitol Hill to explore separate solutions to streamline the FDA review process and update CMS standards related to LDTs.

In a [9/5 letter](https://www.myadlm.org/advocacy-and-outreach/comment-letters/2024/ldt-survey-august-2024?ref=fdaweb.com) to Senate and House lawmakers, the group cautioned that the new rule could potentially impact the ability of clinical laboratories to deliver timely and quality patient care, according to data collected from multiple surveys. For example, ADLM’s June survey found that laboratories faced significant challenges. Over half of the testing facilities reported they would discontinue some LDTs due to difficulties in meeting the new requirements. Additionally, about 60% of hospitals indicated they could not comply with the rule’s unmet need exceptions, with nearly 70% of those facilities planning to discontinue LDTs as a result.