21 CFR Chapter I Subchapter H โ Medical Devices โ Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document on submitting Next Generation Sequencing data to the Division of Antiviral Products, focusing on Clinical - Antimicrobial topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 5, 2020 Other (Public Domain) 0 reuses 0 favorites
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 From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document for stakeholders and FDA staff on designing and validating NGS-based IVDs for diagnosing suspected germline diseases. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2020-01725. The Food and Drug Administration (FDA, the Agency, or we) is classifying the human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology into class II (special controls). The special controls that apply to theโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 7, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2018-13406. The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codifiedโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 22, 2018 Other (Public Domain) 0 reuses 0 favorites
NGS (IVDs) From Health Sciences Authority (HSA) ๐ธ๐ฌ Guidance document on NGS (IVDs) focusing on Product Specific Regulatory Guidelines. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on March 17, 2024 Other (Public Domain) 0 reuses 0 favorites