For Industry

FDA User Fee Programs
Pay user fees for pre-market review, establishment/facility registration, export certificates, color additive certificates, tobacco penalties, and FOIA requests.
FDA User Fee Programs

Import Alerts
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.
Import Alerts

FDA Basics for Industry
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.
FDA Basics for Industry

Navigate the For Industry Section

User Fees

How to pay user, registration, facility, certificate, and other fees. Includes cover sheet submission, invoice payment, and refund requests.

Small Business Assistance

Small Business Guide to working with the FDA

Dispute Resolution

For individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or procedures

Color Additives

Color additive approval and certification, using color additives in different products, safety information, and more

Promoting the development of promising products for the diagnosis or treatment of rare diseases or conditions

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 topics

FDA Basics for Industry

Basic information about the regulatory process in an accessible and user-friendly format.