📘 FDA manuals • Free online PDFs
FDA logo

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 manuals

Selected manuals from manuals+ curated for this brand.

Additional documents are a limited selection. Search all manuals.

FDA U.S. Food and Drug Administration Center Instructions

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

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

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 Mens Plain Face Cream Owner’s Manual

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

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 DTP-1 Lighting the Development Pathway User Guide

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 Forms Management Policy and Procedures

FDA Forms Management Policy and Procedures

Staff Manual Guide
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.

FDA questions and answers

Product questions, troubleshooting answers, and setup help related to this topic.

Ask a question about FDA