FDA Approval

The Food and Drug Administration (FDA) is an agency operating under the United States Department of Health. The FDA is responsible for products directly used by humans and animals, such as food, drugs, medical devices, biomedicals, veterinary clinic instruments, blood products, dietary supplements, and cosmetic products. It issues certificates for these products, ensuring they meet safety and health standards before entering the market. Both domestic and foreign companies involved in the production, processing, and packaging of products designed for human and animal use must obtain FDA certification.

FDA Certification Requirements

The FDA certificate plays a crucial role in preventing bioterrorism, as mandated by United States laws. All domestic and foreign firms producing, packaging, or storing products intended for consumption by humans or animals within the United States must register with the FDA. Products imported from companies outside the United States without FDA registration will not be allowed entry through U.S. ports. FDA approval is necessary for products to be sold and freely circulated in the U.S. market. Product registration processes vary for different types of products.

FDA Application Process

Products intending to apply for FDA approval must undergo standardized tests, similar to those in many countries. Upon passing these tests, products can be approved and introduced to the market. Economic operators attempting to bring products to market without meeting compliance standards face penalties. To obtain FDA approval, product authorities must submit applications to the FDA, and products approved by the FDA can then be released to the market.

FDA Registration and Listing Procedures

All domestic and foreign organizations involved in producing animal drugs in the United States must register with the FDA. Manufacturers, packagers, or relabelers of these products must also list them commercially. This listing process is interconnected with the registration process for drugs produced for humans.

Makeup products are reported through the Voluntary Cosmetic Registration Program. This system is a post-market reporting system used by manufacturers, packagers, and distributors of cosmetic products in the United States.

All organizations, domestic and foreign, producing, packaging, or relabeling drugs in the United States must register with the FDA. Listing is essential for all products to maintain a catalog of all drugs in commercial distribution. The FDA keeps records in various forms to provide information and manage post-market surveillance, counterterrorism efforts, drug shortage situations, and user fee assessments.

Registration and listing procedures for medical devices are specified in 21 CFR Part 807. Congress has authorized the FDA to collect annual registration fees from medical device establishments. Medical devices must be registered and listed with the FDA before entering the market.

Products emitting radiation must file Radiation Safety Reports as required by law. Products successfully evaluated under the Radiological Health Program are registered for market release.

Tobacco products must be registered with the FDA by responsible parties in accordance with the Tobacco Control Act, ensuring legal compliance in their production, preparation, blending, or processing.

Organizations producing cell, tissue, or cellular or tissue-based products for human use must register with the FDA under its regulations and list their products. The production of cellular and tissue-based products involves processes such as recovery, processing, storage, packaging, and labeling. Manufacturers of products directly related to human health, such as blood and vaccines, must register their health products with the FDA.