Manufacturers and operators of businesses also called establishments engaged in production and distribution of medical devices in the United States must register themselves with the FDA. Most establishments that are required to register with the FDA must list the medical devices they manufacture and/or distribute as well as list the activities conducted on those devices. Where a device needs premarket notification or approval prior to marketing in the country, the establishment must submit the FDA premarket submission number as well.
Amendments effected to the Medical Device User Fee Modernization Act mandate that after September 30, 2007; registration as well as listing information must be presented electronically unless a waiver is offered. Listing offers FDA with medical device establishments’ location as well as devices manufactured at these factories or establishments. Determining the location increases the country’s ability to prepare and react to public health emergencies.