# Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-clinical-laboratory-improvement-amendments-of-1988-clia-waiver-applications-for-manufacturers-of-in-vitro-diagnostic-devices-guidance-for-industry-and-food-and-drug-administration-staff/599abc6a-4ceb-42a1-a45e-85d30e64cef0

> FDA guidance document: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices:  Guidance for Industry and Food and Drug Administration Staff. Issue date: February 26, 2020. Get complete insights and analysis.

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## Details

- Title: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices:  Guidance for Industry 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: 2020-02-26
- Last Changed: 2024-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5570">FDA-2017-D-5570</a>

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