# Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases:  Guidance for Stakeholders and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-design-development-and-analytical-validation-of-next-generation-sequencing-ngs-based-in-vitro-diagnostics-ivds-intended-to-aid-in-the-diagnosis-of-suspected-germline-diseases-guidance-for-stakeholders-and-food-and-drug-administration-staff/23d92ad8-5a27-4cf3-986b-82cc58005afd

> FDA guidance document: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases:  Guidance for Stakeholders and Food and Drug Administration Staff. Issue date: April 13, 2018. Get complete insights and analysis.

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## Details

- Title: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases:  Guidance for Stakeholders 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: 2018-04-13
- Last Changed: 2020-03-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-1270">FDA-2016-D-1270</a>

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