"Registering online will be fast and simple," said Commissioner of Food and Drugs Mark B. McClellan. "Our site will be open 24 hours a day, seven days a week, available to anyone in the world with access to the Internet. This new system will permit 400,000 facilities to register worldwide in 60 days."
FDA is encouraging electronic registration because it is faster and more efficient than paper registration. Each firm registering online will receive a unique registration number, which will be required for doing business in the U.S. beginning December 12, 2003. Paper registration may be submitted via regular mail or fax. Facilities will not be charged for registration, which is a one-time procedure.