📘 FDA manuals • Free online PDFs

FDA Manuals & User Guides

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more.

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

FDA Support

Official site: https://www.fda.gov/
General support: https://www.fda.gov/about-fda/contact-fda
Support phone: 1-888-463-6332 — Mon-Fri 8:00am - 4:30pm ET
Support email: webmail@oc.fda.gov
Contact form: Contact manufacturer support

FDA manuals

Latest manuals from manuals+ curated for this brand.

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)…

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…

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…

FDA Authenticator App User Guide

January 30, 2025

Multi-factor Authentication User Guide Authenticator App Multi-factor Authentication (MFA) is a security mechanism to build stronger authentication into the LearnED LMS standard login process. Non-FDA Users who are required to…

FDA Super Retinol Cream for Men Owner’s Manual

January 24, 2025

FDA Super Retinol Cream for Men SUPER RETINOL CREAM FOR MEN- super retinol cream for men cream Yiwu Ziqiu Import Export Co Ltd Salicylic acid 2% Instructions for use Wart…

FDA Mens Plain Face Cream Owner’s Manual

January 24, 2025

FDA Mens Plain Face Cream Specifications Product Type: HUMAN OTC DRUG TOPICAL Item Code (Source): NDC:84522-526 Active Ingredient: Salicylic acid 2% Inactive Ingredients: Acrylates copolymer, Ethyl acetate, NIACINAMIDE, CHLORPHENESIN, GLYCERIN,…

FDA Anti Aging Cream Owner’s Manual

January 24, 2025

FDA Anti Aging Cream Product Specifications Product Name: Anti-Aging Cream Product Type: Topical Cream Active Ingredient: Niacinamide Strength: 5 g in 100 g Inactive Ingredients: Sesame Oil, Glycerin, Chlorphenesin, Palmitoyl…

FDA Meta Quest 3 Mixed Reality Headset 128 GB User Guide

January 2, 2025

FDA Meta Quest 3 Mixed Reality Headset 128 GB User Guide Purpose This document is intended to support users of the Lilypad™ VR experience. It outlines the technical requirements, processes…

FDA DTP-1 Lighting the Development Pathway User Guide

November 27, 2024

Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs Karthika Natarajan Staff Fellow, DTP-1 | ORS | OGD CDER | U.S. FDA Facilitating Generic Drug Product Availability through…

FDA Information Technology Strategy User Guide

November 13, 2024

FDA Information Technology Strategy for Fiscal Years 2024 to 2027 Message from the CIO I am pleased to share our annual publication of the FDA IT Strategy for FY 2024…

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

Laboratory Method

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.

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

Guidance Document

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.

GUDID User Manual: How to Unlock and Edit Device Records in the FDA Database

User Manual

User manual providing instructions on how to unlock and edit device records within the FDA's Global Unique Device Identification Database (GUDID), covering the unlock process, editing procedures, and important considerations…

FDA Food Facility Registration User Guide: Additional Capabilities

User Guide

A comprehensive user guide from the U.S. Food & Drug Administration (FDA) detailing additional capabilities within the Food Facility Registration (FFR) system, including managing registrations, cancellations, and searching facility information.

FDA ACE Supplemental Guide: Industry Quick Reference Guide v2.5.3

Guide

A comprehensive quick reference guide for importers and filers on reporting information to the FDA for regulated products entering the United States via the Automated Commercial Environment (ACE) system, covering…

FDA Staff Manual Guide 1121.934: Northeast Food and Feed Laboratory Organizations and Functions

Staff Manual

Official FDA Staff Manual Guide 1121.934 detailing the organizational structure and functional responsibilities of the Northeast Food and Feed Laboratory (DCIFCD) and its branches, including Chemistry Branch 1, Chemistry Branch…

Aseptic Processing of Biological Products: Current Regulatory Issues and Manufacturing Challenges

Guidance Document

Guidance on current regulatory issues and common deficiencies in aseptic processing of biological products, covering laws, regulations, BLA content, process validation, sterilizing filtration, post-reconstitution/dilution storage, and container closure integrity. Presented…

FDA Manuals & User Guides

FDA manuals

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

FDA U.S. Food and Drug Administration Center Instructions

FDA NDA 215014-S-008 Empaveli REMS Instructions

FDA Authenticator App User Guide

FDA Super Retinol Cream for Men Owner’s Manual

FDA Mens Plain Face Cream Owner’s Manual

FDA Anti Aging Cream Owner’s Manual

FDA Meta Quest 3 Mixed Reality Headset 128 GB User Guide

FDA DTP-1 Lighting the Development Pathway User Guide

FDA Information Technology Strategy User Guide

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

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

GUDID User Manual: How to Unlock and Edit Device Records in the FDA Database

FDA Food Facility Registration User Guide: Additional Capabilities

FDA ACE Supplemental Guide: Industry Quick Reference Guide v2.5.3

FDA Staff Manual Guide 1121.934: Northeast Food and Feed Laboratory Organizations and Functions

Aseptic Processing of Biological Products: Current Regulatory Issues and Manufacturing Challenges

Bacteriological Analytical Manual Chapter 23: Methods for Cosmetics - FDA

FDA ESG NextGen AS2 Guide for Industry Users - Version 2.0

Making ACE Work for You: Importing FDA Regulated Products Guide

ANDA Submissions: Content and Format Guidance for Industry

FDA Guide to Documents, Change Control, and Records Management