- Pay user fees for pre-market review, establishment/facility registration, export certificates, color additive certificates, tobacco penalties, and FOIA requests.
- Import Alerts prevent products that may not meet FDA standards from being distributed in the U.S. and make importers responsible for ensuring products aren't adulterated or misbranded.
- At-a-glance tables to point you to the regulations you need
- FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry.
Navigate the For Industry Section
FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.Small Business Assistance
Small Business Guide to working with the FDADispute Resolution
For individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or proceduresColor Additives
Color additive approval and certification, using color additives in different products, safety information, and moreDeveloping Products for Rare Diseases & Conditions
Promoting the development of promising products for the diagnosis or treatment of rare diseases or conditions
Links to prepare cover sheets and pay user fees for pre-market product reviews, and to pay for establishment/facility registrations, export certificates, color additive certificates, tobacco civil money penalties, and FOIA requests.Electronic Submissions Gateway
Information on how to submit documents to FDA electronically.FDA eSubmitter
An electronic submissions program for the device, radiological health and blood regulated industries.Import Program
Information for FDA personnel, import brokers, wholesalers, retailers and consumers about import products.Data Standards
Information about the FDA Data Standards Council and other data standards topicsIndustry Notices and Guidance Documents
Information for industry about FDA guidance documents and notices to industry
Resources for You
Approvals of FDA-Regulated Products MedWatch: The FDA Safety Information and Adverse Event Reporting Program Recalls, Market Withdrawals, & Safety Alerts Search for FDA Guidance Documents Inspection, Compliance, Enforcement, and Criminal Investigations Driving Biomedical Innovation: Initiatives for Improving Products for Patients Clinical Trials and Human Subject Protection Get Email Updates