FDA Manuals & User Guides

FDA 2024 CE Rare Disease Day Credit Claiming Instructions

March 11, 2024

FDA 2024 CE Rare Disease Day Credit Claiming CE Credit Claiming Instructions *Must be completed by March 15, 2024 Step 1: Log in to the CE Portal Go to https://ceportal.fda.gov FDA Employees – sign in with single sign-on Non-FDA Participants-…

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FDA K230087 Point Kinguide Agile Hybrid Navigation System Instructions

February 23, 2024

FDA K230087 Point Kinguide Agile Hybrid Navigation System Product Information Specifications Trade/Device Name: POINT Kinguide Agile Hybrid Navigation System Regulation Number: 21 CFR 882.4560 Regulatory Class: Class II Product Code: OLO Product Usage Instructions Indications for Use The POINT Kinguide…

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FDA Product Tracing System (PTS) Owner’s Manual

January 22, 2024

FDA Product Tracing System (PTS) Product Tracing System (PTS) Specifications Application Hosting: Amazon Web Services (AWS) Front End Development: Django Data Analytics & AI/ML: Domino Data Labs & Amazon Sagemaker Data Visualization: Qlik Advancing Food Traceability through Innovation The Product…

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FDA AD-0602-Band D Vacancy Announcement Branch Chief User Guide

January 21, 2024

AD-0602-Band D Vacancy Announcement Branch Chief Title 21 Vacancy Announcement Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) Office of Clinical Evaluation (OCE) Division…

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FDA 7500 Fast Instrument Instruction Manual

January 15, 2024

FDA 7500 Fast Instrument Standard Operation Procedure –Molecular Detection of Cyclospora caye tanensis in Fresh Produce Using Real-Time PCR. Produce Washing and DNA Extraction Procedures This analytical procedure provides steps for isolation of C. caye tanensis oocysts from produce by…

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FDA MD-8150 COVID-19 Antigen At Home Test Instruction Manual

January 2, 2024

MD-8150 COVID-19 Antigen At Home Test Instruction Manual MD-8150 COVID-19 Antigen At Home Test Nano-Check™ COVID-19 Antigen At-Home Test Quick Reference Instruction Catalog No. MD-8150 For Use Under an Emergency Use Authorization(EUA) Only For In Vitro Diagnostic Use, For Use…

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FDA 21 Vacancy Announcement User Guide

December 31, 2023

FDA 21 Vacancy Announcement Product Information Specifications Position: Deputy Office Director Series: AD-0602 Location(s): Silver Spring, Maryland Work Schedule: Full Time Cures Band(s): Band F Salary: Starting at $210,000 Full Performance Band Level: Band F Travel Requirements: 25% or less…

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FDA-2023-D-4722 Milk and Cream Products and Yogurt User Guide

December 12, 2023

FDA-2023-D-4722 Milk and Cream Products and Yogurt Product Information Specifications Product Name: Milk and Cream Products and Yogurt Products Standards Revoked: Lowfat Yogurt and Nonfat Yogurt Standard Amended: Yogurt Regulatory Authority: Food and Drug Administration (FDA) Regulatory Code: 21 CFR…

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FDA TangenDx SARS-CoV-2 Molecular Test Instruction Manual

December 8, 2023

U.S. FOOD & DRUG ADMINISTRATION TangenDx SARS-CoV-2 Molecular Test September 29, 2023 Glenn Neuman RADx Regulatory Consultant New World Regulatory Solutions, Inc. Representing: Tangen Biosciences, Inc. 20 Commercial St. Branford, CT 06405 Device:   TangenDx SARS-CoV-2 Molecular Test  EUA Number: EUA230015…

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FDA Hold Webinar on the Food Traceability Final Rule User Guide

December 7, 2023

FDA Hold Webinar on the Food Traceability Final Rule User Guide Welcome To Today’s Webinar Thanks for joining us! We’ll get started in a few minutes Today’s Topic: FDA’s Proposed Rule Regarding Laboratory Developed Tests Date: October 31, 2023 Proposed…

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