The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires all non-U.S. facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.
U.S. Medical Device Establishments that are not exempt from U.S. FDA’s registration and listing requirements must designate an Official Correspondent for U.S. FDA communications. Most establishments that are required to register with the FDA are also required to list the devices and the activities that are performed on those devices.
FDA uses the information to evaluate cosmetic products on the market. Because product filings and establishment registrations are not mandatory, voluntary submissions provide FDA with the best information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution.
