FDA Manuals & User Guides

FDA 2BVLC-PREX Laser Engraver Instruction Manual

May 19, 2026

FDA 2BVLC-PREX Laser Engraver FCC Requirement Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is…

Brand: FDA

FDA Pifeltro Doravirine Tablet of Hiv Infection User Manual

January 2, 2026

FDA Pifeltro Doravirine Tablet of Hiv Infection INDICATIONS AND USAGE PIFELTRO® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment…

Brand: FDA

FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Instructions

January 1, 2026

FDA natalizumab-sztn Tyruko First and Only Multiple Sclerosis Biosimilar Specifications Product Name: TYRUKO Indication: Integrin receptor antagonist for the treatment of Multiple Sclerosis (MS) Dosage Form: Injection Strength: 300 mg/15 mL (20 mg/mL) solution IMPORTANT SAFETY INSORMATION WARNING: PROGRESSIVE MULTIFOCAL…

Brand: FDA

FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection User Guide

December 25, 2025

FDA 761440s000lbl Blenrep Belantamab Mafodotin Blmf Injection Specifications Product Name: BLENREP Generic Name: Belantamab Mafodotin-blmf Administration: Intravenous Use Approval Year: 2020 Dosage Form: Lyophilized powder for injection Strength: 70 mg Contraindications There are no contraindications listed for BLENREP use. HIGHLIGHTS…

Brand: FDA

FDA approves Abbott TriClip TEER System User Manual

November 11, 2025

FDA approves Abbott TriClip TEER System This Patient guide is for those who have severe tricuspid regurgitation (TR) but continue to have symptoms despite being on heart failure medication. Be sure to ask your Heart Team to explain all your…

Brand: Abbott

FDA ESG NEXTGEN App User Guide

April 5, 2025

FDA Electronic Submission Gateway (ESG) NextGen API Guide FDA Electronic Submission Gateway (ESG) NextGen API Guide Application Program Interface Version 1.0 March 2025 1. Introduction This document provides guidelines for submitting files and folders through Application Programming Interfaces (APIs) with…

Brand: FDA

FDA AS2 Electronic Submission Gateway Next Gen User Guide

April 5, 2025

FDA AS2 Electronic Submission Gateway Next Gen Product Usage Instructions This guide is intended for industry participants who want to utilize AS2 to submit regulatory information to the FDA. The audience includes current AS2 submitters and user technical support resources.…

Brand: FDA

FDA V-8.F Supplemental Method for Whole Bay Leaves Instructions

March 7, 2025

Macroanalytical Procedures Manual (MPM) V-8. Spices, Condiments, Flavors, and Crude Drugs F. Supplemental Method for Whole Bay Leaves February 2025 Editor (s): Hans Loechelt-Yoshioka Co-editor(s): Amy Barnes, Richard Haynos (Retired) F. Supplemental Method for Whole Bay Leaves Scope This method…

Brand: FDA

FDA U.S. Food and Drug Administration Center Instructions

March 6, 2025

U.S. Food and Drug Administration Center for Devices and Radiological Health Digital Health Advisory Committee (DHAC) Meeting on the topic "Total Product Lifecycle Considerations for Generative AI-Enabled Devices" Summary Minutes for Day 1 - November 20, 2024 Introduction On November…

Brand: FDA

FDA NDA 215014-S-008 Empaveli REMS Instructions

February 4, 2025

FDA NDA 215014-S-008 Empaveli REMS Product Usage Instructions Program Implementation and Operations REMS Program Implementation (6-month and 1-year assessments only): Date of first commercial distribution of Empaveli. Date of Empaveli REMS launch. Date when the REMS Website became live and…

Brand: FDA

MAPP 5015.14: Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs

manual • May 7, 2026

FDA Manual of Policies and Procedures (MAPP 5015.14) outlining the prioritization criteria for off-cycle solicited Type II Drug Master File (DMF) amendments associated with ANDAs or PASs.

Brand: FDA

FDA CDER Direct: Electronic Submissions Portal for Product Listing and Registration

Guide • April 14, 2026

An overview of the FDA's CDER Direct Electronic Submissions Portal, detailing its features, benefits, user types, available SPL forms, and frequently asked questions for product registration and listing.

Brand: FDA

CFSAN Online Submission Module (COSM) Quick Start Guide

Quick Start Guide • April 6, 2026

A quick start guide for using the CFSAN Online Submission Module (COSM) to submit regulatory documents to the U.S. Food and Drug Administration (FDA), covering registration, login, contact management, submission assembly, and sending documents.

Brand: FDA

FDA ACE Error Guide: Understanding and Resolving Entry Rejection Messages

Guide • March 26, 2026

A comprehensive guide from the U.S. Food & Drug Administration (FDA) detailing reject messages encountered in the ACE system, providing definitions, status codes, and contact information for resolution.

Brand: FDA

Proprietary Names: Center for Veterinary Medicine Program Policy and Procedures Manual

Policy and Procedures Manual • March 11, 2026

This document outlines the policies and procedures for identifying, formatting, and using proprietary names within the Center for Veterinary Medicine (CVM) for animal drug evaluations, including administrative processes and documentation guidelines.

Brand: FDA

Bioanalytical Method Validation for Biomarkers: FDA Guidance for Industry

guide • February 20, 2026

Guidance from the U.S. Food and Drug Administration (FDA) on validating bioanalytical methods for biomarkers in drug development. Covers scope, purpose, and key validation characteristics for nonclinical and clinical studies.

Brand: FDA

FDA CDER MAPP 6025.4: Good Review Practice - Refuse To File Policy

Policy Manual • February 17, 2026

This document outlines the policies, responsibilities, and procedures for the FDA's Center for Drug Evaluation and Research (CDER) Office of New Drugs staff regarding the 'Refuse To File' (RTF) process for New Drug Applications (NDAs) and Biologics License Applications (BLAs).

Brand: FDA

Write It Right: Recommendations for Developing User Instruction Manuals for Home Health Care Medical Devices

Guidance Document • January 4, 2026

Guidance from the U.S. Food and Drug Administration (FDA) on creating clear, accessible, and effective user instruction manuals for medical devices intended for home health care. This document assists manufacturers in planning, writing, designing, and testing manuals to ensure safe and effective…

Brand: FDA

Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition

Guidance • December 31, 2025

Guidance for the fish and fishery products industry on developing HACCP plans, identifying hazards (biological, chemical, physical), and implementing control strategies for seafood safety, covering pathogens, toxins, allergens, and contaminants.

Brand: FDA

FDA Forms Management Policy and Procedures

Staff Manual Guide • December 24, 2025

Official policy and procedural guide from the Food and Drug Administration (FDA) detailing the development, management, and lifecycle of agency forms, including printed and electronic formats, ensuring compliance and efficiency.

Brand: FDA

Elemental Analysis Manual for Food: ICP-MS Method for Trace Elements

Laboratory Method • December 24, 2025

Detailed laboratory method by the U.S. FDA for determining trace elemental concentrations in food using ICP-MS and Microwave Assisted Digestion. Covers Arsenic, Cadmium, Chromium, Lead, Mercury, and other key elements.

Brand: FDA

Guidance for Biological Indicator (BI) Premarket Notification [510(k)] Submissions

Guidance Document • December 22, 2025

FDA guidance document for industry on preparing Premarket Notification (510(k)) submissions for Biological Indicators (BIs) used in healthcare sterilization monitoring. Covers device description, performance characteristics, and regulatory requirements.

Brand: FDA