In a Federal Register Final Rule published on August 2, 2012, the Food and Drug Administration (FDA) announced the implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which will require domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the time frames when establishments are required to submit such information.

According to the ruling, FDA will be "eliminating the need for a feasibility finding, and requiring both foreign and domestic establishment registration and device listing information to be submitted using electronic means unless FDA grants a waiver request. Electronic registration and product listing would be completed via FDA’s Unified Registration and Listing System (FURLS) for devices, an Internet-based system that became operational on October 1, 2007. FDA believes this electronic system will ultimately make the process of submitting registration and listing information for devices more efficient for industry and will provide faster access to this information for both FDA and industry."

Other significant changes listed in the Register ruling include:
- Removing the exemptions from registration and listing requirements for devices entering foreign trade zones.
- Requiring exempt devices to be identified by product code rather than by classification name and number.

This final rule will become effective on October 1, 2012.

The full text of the Federal Register notice is available online here.