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# LDT Oversight Legislation Needed: Pew Research
- URL: https://www.fdaweb.com/ldt-oversight-legislation-needed-pew-research/
- Published: 2021-10-26T12:00:00.000Z
- Updated: 2026-09-14T17:20:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150443

The Pew Charitable Trusts says Congress should pass legislation to increase the transparency of the market for laboratory-developed tests (LDTs) and authorize FDA to review the tests based on their risk to patients. In an online [report](https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2021/10/diagnostic-tests-not-reviewed-by-fda-present-growing-risks-to-patients?ref=fdaweb.com), Pew says that because LDTs are not centrally registered or tracked, no one knows precisely how many of them are on the market, when and why they are used, or how their performance compares to FDA-approved tests.

“Whether FDA approves them or not,” the report says, “all tests run the risk of delivering a false result. However, because labs are not required to publicly report adverse events associated with LDTs to a central authority, there is no comprehensive data quantifying the number and nature of incidents tied to inaccurate LDTs.”

Pew calls on Congress to pass diagnostics reform legislation that: 

- requires developers of LDTs to register their tests with FDA and report adverse events related to their products;
- allows the agency to require that higher-risk LDTs be reviewed for both analytical and clinical validity before they are used on patients; and
- authorizes FDA to obtain information from LDT makers about the validity and performance of their tests once on the market.