FDA Manuals & User Guides

User manuals, setup guides, troubleshooting help, and repair information for FDA products.

Tip: include the full model number printed on your FDA label for the best match.

FDA manuals

Latest posts, featured manuals, and retailer-linked manuals for this brand tag.

FDA K240280 Nano Check RSV Test Instructions

FDA K240280 Nano Check RSV Test Instructions

September 30, 2024
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) Number  K240280 B Applicant  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information Product Code(s) Classification Regulation Section Panel GQG Class I 21 CFR 866.3480 - Respiratory Syncytial Virus…
Brand: FDA
FDA h:2250.1 Metered Mail Headquarters Instructions

FDA h:2250.1 Metered Mail Headquarters Instructions

August 23, 2024
FDA h2250.1 Metered Mail  Purpose This Guide sets forth requirements for the metering of outgoing administrative mail at Headquarters locations in order to prepay USPS postage costs. Background In order to more accurately assess postage costs and more effectively satisfy…
Brand: FDA
FDA CFSAN Online Submission Module User Guide

FDA CFSAN Online Submission Module User Guide

August 15, 2024
FDA CFSAN Online Submission Module INTRODUCTION This Guide will briefly introduce you to the CFSAN Online Submission Module (COSM) and illustrate how to assemble an OFAS Regulatory submission. COSM presents you with questions in a simple and consistent format to…
Brand: FDA
FDA CFSAN Submission Module User Guide

FDA CFSAN Submission Module User Guide

August 15, 2024
FDA CFSAN Submission Module Product Information Specifications Product Name: CFSAN Online Submission Module (COSM) Availability: 24 hours, 7 days a week Developed for: Transmitting submissions to FDA's CFSAN Product Usage Instructions COSM Registration Process The COSM registration process involves creating…
Brand: FDA
FDA 2004-N-0451 Food and Drug Instructions

FDA 2004-N-0451 Food and Drug Instructions

July 31, 2024
FDA 2004-N-0451 Food and Drug Specifications Product Name: Food and Drug Administration Modernization Act of 1997 Recognition List Number: 062 Agency: Food and Drug Administration, HHS Product Usage Instructions Registration for Workshop Attendance To attend the workshop, registration is required.…
Brand: FDA
FDA Viramune Oral Suspension Tablet Instructions

FDA Viramune Oral Suspension Tablet Instructions

July 6, 2024
FDA Viramune Oral Suspension Tablet Instructions Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about…
Brand: FDA
FDA Zyprexa Olanzapine Tablet Instructions

FDA Zyprexa Olanzapine Tablet Instructions

July 6, 2024
FDA Zyprexa Olanzapine Tablet Product Information Specifications: Product Name: ZYPREXA Generic Name: Olanzapine Form: Tablet, Orally Disintegrating Product Usage Instructions: Before starting ZYPREXA, read the Medication Guide provided with the medication and review it each time you get a refill.…
Brand: FDA
FDA COVID-19 Flu Antigen Self Test Instruction Manual

FDA COVID-19 Flu Antigen Self Test Instruction Manual

July 1, 2024
FDA COVID-19 Flu Antigen Self Test Specifications: Product Name: QuickFinderTM COVID-19/Flu Antigen Self Test Intended Use: Qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B protein antigens Age Requirement: Individuals aged 14 years or older for self-collected specimens,…
Brand: FDA
Bioresearch Monitoring Technical Conformance Guide

Bioresearch Monitoring Technical Conformance Guide

guidance • July 28, 2025
This guide provides FDA specifications, recommendations, and general considerations for preparing and submitting Bioresearch Monitoring (BIMO) clinical data in electronic format for new drug applications (NDAs) and biologics license applications (BLAs). It details requirements for Clinical Study-Level Information, Subject-Level Data Line Listings…
Brand: FDA