# Laboratory Developed Tests: Small Entity Compliance Guide:  Guidance for Laboratory Manufacturers and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/laboratory-developed-tests-small-entity-compliance-guide-guidance-for-laboratory-manufacturers-and-food-and-drug-administration-staff/96c89968-a780-4018-8eca-3d679d71ed9e

> FDA guidance document: Laboratory Developed Tests: Small Entity Compliance Guide:  Guidance for Laboratory Manufacturers and Food and Drug Administration Staff. Issue date: June 25, 2024. Get complete insights and analysis.

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## Details

- Title: Laboratory Developed Tests: Small Entity Compliance Guide:  Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2024-06-25
- Last Changed: 2024-06-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-N-2177">FDA-2023-N-2177</a>

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