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# Guide on Lab-Developed Test Compliance Guide
- URL: https://www.fdaweb.com/guide-on-lab-developed-test-compliance-guide/
- Published: 2024-06-25T12:00:00.000Z
- Updated: 2026-09-14T14:34:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157243

*Federal Register* notice: FDA is making available a final guidance entitled “Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.” The document is intended to help small entities comply with applicable medical device regulations, consistent with the LDT final rule, including a phase-out of FDA’s general enforcement discretion approach for LDTs so that IVDs manufactured by a lab will generally fall under the same enforcement approach as other IVDs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-06-25/pdf/2024-13872.pdf?ref=fdaweb.com).