Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Device Exemption (HDE)).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted. The establishment registration fee is not eligible for a reduced small business fee.
Registration and listing provide FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.