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In this section: Biologics Rules

General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules

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Notices

Federal Register Notice: Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program; Request for Comments
6/21/2022

Proposed Orders

None

Final Orders

Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
6/15/2022

Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology
2/7/2020

Proposed Rules

None

Final Rules

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