Registration with the Food and Drug Administration (FDA) in the USA is an important step for companies wishing to introduce products into the American market. The FDA is responsible for monitoring and regulating food, drugs, medical devices and cosmetics in the United States. In this article, we provide an overview of who needs to register, which products are covered by the registration, and the requirements for non-US companies.
- Who must register? Companies that want to manufacture, process, package, or import food, dietary supplements, drugs, medical devices, or cosmetics into the United States must register with the FDA. This applies to both domestic and foreign companies. Registration is mandatory and allows the FDA to verify compliance with safety standards and regulations.
- Products that must be registered: (a) Food: This includes both packaged foods and dietary supplements. FDA has specific requirements for labeling, ingredients, and manufacturing practices. b) Drugs: this includes prescription and over-the-counter drugs. The FDA regulates the safety, efficacy, and quality of drugs. c) Medical Devices: This includes instruments, apparatus, machines, or supplies used to diagnose, treat, or prevent disease. The FDA reviews the safety and performance of such devices. d) Cosmetics: This includes products such as skin care products, hair care products, makeup, and perfumes. The FDA ensures that cosmetics are safe to use and do not pose health risks.
- Requirements for non-US companies: Non-U.S. companies wishing to import products into the U.S. must meet the following requirements in addition to the FDA filing: (a) Designation of a U.S. Agent: Non-U.S. companies must designate a U.S.-based agent or representative to serve as a contact person for the FDA. SPACEGOATS can help with this! b) Submission of a Prior Notice: prior to importing food, companies must submit a Prior Notice to FDA to notify the agency of the proposed import.
Summary: Notification to FDA is critical for companies seeking to import products into the United States. Food, drugs, medical devices, and cosmetics are subject to registration. Non-U.S. companies must also designate a U.S. representative and file a Prior Notice for food imports. Ensuring compliance with FDA regulations.