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
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 13, 2018
March 2, 2020
23d92ad8-5a27-4cf3-986b-82cc58005afd
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