FDA Manuals & User Guides

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

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FDA manuals

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

FDA Premarket Tobacco Product Application User Guide

FDA Premarket Tobacco Product Application User Guide

October 4, 2023
U.S. Food and Drug Administration Center for Tobacco Products (CTP) Product Form Validator Tool User Guide Document Version Number: 1 September 2023 Introduction The FDA Center for Tobacco Products (CTP) requires that a Premarket Tobacco Product Application (PMTA) include scientific…
Brand: FDA
FDA Advancing Health Medical Devices Instruction Manual

FDA Advancing Health Medical Devices Instruction Manual

September 3, 2023
EXECUTIVE SUMMARY FOR THE PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING Advancing Health Equity in Medical Devices Disclaimer: This Executive Summary is for discussion purposes only and does not represent draft or final guidance. It is not intended to propose or implement…
Brand: FDA
FDA Department of Health and Human Services Instructions

FDA Department of Health and Human Services Instructions

August 29, 2023
FDA Department of Health and Human Services Instructions 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 Vaccines Research and Review (OVRR) Division of…
Brand: FDA
FDA Optilume BPH Catheter System Instruction Manual

FDA Optilume BPH Catheter System Instruction Manual

August 12, 2023
FDA Optilume BPH Catheter System Product Information The Optilume BPH Catheter System is a medical device designed for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in patients 50 years of age or older. It is…
Brand: FDA
FDA SurVeil Drug-Coated Balloon User Guide

FDA SurVeil Drug-Coated Balloon User Guide

August 12, 2023
FDA SurVeil Drug-Coated Balloon Product Information The SurVeilTM Drug-Coated Balloon is a medical device authorized by Federal (U.S.) law for the treatment of peripheral artery disease (PAD). It is specifically designed to treat femoral or popliteal artery stenosis, which is…
Brand: FDA
FDA Title 21 Vacancy Announcement Instructions

FDA Title 21 Vacancy Announcement Instructions

August 5, 2023
FDA Title 21 Vacancy Announcement Introduction The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds…
Brand: FDA
FDA Breast Implants Instructions

FDA Breast Implants Instructions

July 22, 2023
FDA Breast Implants Product Information: Breast Implants Breast implants are medical devices that are used for breast augmentation, reconstruction, or revision surgery. Before undergoing any breast implant surgery, it is crucial to carefully consider several important factors. The U.S. Food and…
Brand: FDA
FDA Quantitative Immuno PCR Detection Instruction Manual

FDA Quantitative Immuno PCR Detection Instruction Manual

July 4, 2023
FDA Quantitative Immuno PCR Detection Product Information The product is a quantitative immuno-PCR assay designed for the detection of plasma IP-10 levels over time. It is specifically developed as a candidate pharmacodynamic biomarker of IFN-1 biologics, such as interferon beta-1a…
Brand: FDA
FDA Bio-Self COVID-19 Antigen Home Test Instruction Manual

FDA Bio-Self COVID-19 Antigen Home Test Instruction Manual

June 22, 2023
FDA Bio-Self COVID-19 Antigen Home Test Instruction Manual INTENDED USE The Bio-SelfTM COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription…
Brand: FDA