The Year 2000 Problem, or "millennium bug," occurs in computer-operating systems and applications software whose designers conserved storage space by eliminating the first two digits of the year when encoding date information. Authors of these programs did not expect that they would be used in the year 2000, but such software continues to be used throughout industry and government. In clinical medicine, programs that control monitoring and medication delivery equipment may malfunction or shut down if they are not modified to address this problem.

The FDA Web site was developed to collect responses to a request by the agency that manufacturers provide information about compliance for all products expected to be in service on 1 January 2000. Although originally intended to assist federal agencies that purchase medical devices and laboratory equipment, the resource's audience has been expanded to include the private sector.

Visitors to the site may search a database to find out whether a product has Year 2000 compliance problems. ("Year 2000 compliance" means that a device accurately processes and stores date and time data during, from, into, and between the 20th and 21st centuries.) If a product is not yet compliant, the database provides space for a description of the problem, as well as any planned solution and implementation date. Manufacturers may use the site to submit information about their products electronically and can return to update their existing entries in the database.

In September, U.S. Senator Christopher J. Dodd criticized the slowness of the biomedical equipment industry in responding to the FDA's request for information about compliance, stating that only 755 of 1935 companies contacted by the agency had provided information.