To protect the public from harmful medical devices, the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act expanded FDA’s responsibility for regulating medical devices in the United States. FDA uses three primary mechanisms to ensure that all medical devices are safe and effective for their intended use: Premarket review is a system of checks, reviews, and controls intended to be applied before new devices are approved and made available to the public. On-site inspections of device manufacturers’ facilities are intended to ensure compliance with FDA laws and regulations, including good manufacturing practices (GMP), and prevent the production and marketing of defective devices. The adverse event reporting system is intended to provide FDA with early warning of problems associated with devices after they become available for public use. This monitoring system gathers information about device problems that could necessitate withdrawing a device from the market or taking other corrective actions. Among other things, the act authorized FDA to establish a reporting system for adverse events associated with the use of medical devices. As a result, FDA established the Mandatory Medical Device Reporting (MDR) system. Under this system, since 1984, manufacturers of medical devices have been required to report to FDA—and maintain records on—device- related deaths, serious injuries, and malfunctions that, should they recur, would be likely to result in death or serious injury. A system called the Medical Device and Laboratory Problem Reporting Program (PRP) was established to receive voluntary reports from health care professionals. FDA’s responsibility is to audit manufacturers’ performance to identify systemic problems and trends associated with an individual firm, a specific device, or the entire device industry, issuing guidance as necessary. The Office of Surveillance and Biometrics (OSB) within CDRH operates the adverse event reporting system. OSB reviews adverse event reports on medical devices to identify, manage, and resolve public health issues; prepares safety alerts and public health advisories; and provides regulatory guidance on adverse event reporting issues. CDRH estimates that it spent approximately $8 million and used about 80 full-time-equivalent (FTE) positions in support of the medical device reporting program in fiscal year 1996. This represents an increase of about $606,000 and three FTEs over medical device reporting program expenditures in fiscal year 1995. When FDA receives an adverse event report, OSB health care analysts evaluate and compare the report with other information contained in FDA databases. A decision is then made about whether or not the device problem poses a potential risk to the public health. If so, depending on the nature and severity of the risk, an analyst may initiate a follow-up investigation, which generally involves a written request for additional information or an inspection of the manufacturer or user facility. (App. II provides a detailed description of FDA’s report evaluation process.) For years, FDA’s implementation and enforcement of the medical device reporting regulation have concerned the Congress. Studies issued by our office, the former Office of Technology Assessment, and the Office of Inspector General of the Department of Health and Human Services (HHS) have found significant weaknesses in FDA’s ability to gather information about medical devices in use. For example, in 1986, we found that less than 1 percent of the device problems occurring in hospitals were reported to FDA and that, the more serious the problem with the device, the less likely it was to be reported to FDA. In a follow-up study, we concluded that the problem still existed despite full-scale implementation of the medical device reporting regulation. To improve the flow of information about medical device problems to FDA’s adverse event reporting system, the Congress passed SMDA requires the establishment of a network of communication about device-related events among user facilities, distributors, manufacturers, and FDA. The act requires that user facilities report to FDA—and to device manufacturers, if known—when they become aware of information that reasonably suggests that a device caused or contributed to a death. User facilities are also required to report to manufacturers when they become aware of information that reasonably suggests that a device caused or contributed to a serious injury or serious illness. In the event that the manufacturer of the device is unknown, the facility is required to report a serious injury or illness directly to FDA. User facilities are required to submit reports within 10 work days of becoming aware of such situations. The act also requires that user facilities submit to FDA semiannual summaries of all the adverse event reports they submitted to manufacturers and FDA during the previous 6 months. Table 1 summarizes the medical device reporting requirements for user facilities, distributors, and manufacturers. In addition, SMDA reporting requirements. In addition to the statutory requirement that user facilities and distributors report serious medical device-related events to FDA and manufacturers, the tentative medical device reporting regulation provided nonmandatory guidance. This guidance instructed user facilities to establish and maintain written procedures that include (1) training and educational programs to inform employees about how to identify and report reportable events, (2) internal systems for documenting and reporting adverse events, and (3) documentation and recordkeeping guidelines. In December 1995, 4 years after the tentative medical device reporting regulation was issued, FDA published the final regulation for user facilities and manufacturers. As of July 31, 1996, they are both required to report device-related events under a uniform system of reporting. Also under the final medical device reporting regulation, manufacturers are required to submit baseline reports and annual certifications to FDA. FDA can issue various types of written notification to inform a user facility that it has not complied with the medical device reporting regulation, which could result in civil monetary penalties or warning letters. CDRH established the Manufacturer and User Device Experience (MAUDE) system to replace the PRP and MDR systems. From 1992 to 1996, voluntary reports from user facilities, distributors, and health professionals were input into the MAUDE system; as of April 1996, the MAUDE system contained approximately 20,000 such reports. During this same period, FDA continued to enter manufacturer reports into the MDR system. FDA plans to begin entering into the MAUDE system manufacturers’ reports that give July 31, 1996, or later as the date the manufacturer learned of an adverse event. FDA expects to have moved all the data from the PRP and MDR systems into the MAUDE system by January 1997. Finally, in 1993, FDA established the Medical Products Reporting Program—called “MedWatch”—to encourage health professionals to report adverse events and product problems to FDA, simplify reporting, and improve the postmarket product information in FDA’s adverse event reporting system. MedWatch consists of two forms used to elicit the information needed to monitor the safety of marketed devices: the form 3500 is completed by health professionals for voluntary reporting, and the form 3500A is completed by user facilities, distributors, and manufacturers for required reporting. Using the 3500A was voluntary until the final medical device reporting regulation became effective in July 1996. Although the flow of information to FDA about medical device problems increased dramatically after SMDA is directly responsible for this growth is unclear because the majority of reports were provided by manufacturers rather than by user facilities. The increased volume posed problems for CDRH’s adverse event reporting system, and CDRH experienced significant delays in processing and reviewing reports of potentially hazardous device problems. These delays could hinder the timely identification and resolution of device problems. Moreover, the annual volume of reporting is expected to rise significantly in fiscal year 1997 due, in part, to increased reporting requirements under the final medical device reporting regulation. To speed processing and analysis of reports, FDA has initiated several changes to its adverse event reporting system. Manufacturer reports of medical device problems increased dramatically after SMDA directly accounted for the increased volume of reports because, until recently, FDA did not systematically collect information on the source of complaints. Device manufacturers submitted over 370,400 of the approximately 407,700 (91 percent) adverse event reports that FDA received from all sources during fiscal years 1991 through 1995. A comparison of two 4-year periods, fiscal years 1987 through 1990 and 1991 through 1994, illustrates the rapid growth of FDA officials believe the upward trend in reporting is due to (1) the unanticipated, large volume of problems associated with silicone gel-filled breast implants, which accounted for nearly one-third of all of the manufacturer event reports submitted to FDA during fiscal years 1992 through 1994, and (2) increased compliance by manufacturers with the 1984 medical device reporting regulation and SMDA . CDRH has had considerable difficulty processing and reviewing the heavy volume of adverse event reports in a timely manner. Between March 1994 and April 1995, a backlog of about 48,900 malfunction reports from manufacturers accumulated at CDRH. Many of the malfunction reports were not entered into the adverse event reporting system and available for complete review and assessment until 1996. Although FDA assigns malfunction reports a lower priority than reports of death and serious injury, processing malfunction reports quickly is critical because of their potential to alert FDA to device problems that could cause or contribute to a death or serious injury if the malfunction were to recur. Entering all adverse event reports into the system promptly allows FDA analysts to perform more complete reviews and assessments on device problems. Further, entering event reports expeditiously is important because an event report, regardless of whether it requires immediate action, can become part of a group of reports that ultimately stimulates corrective action on a device problem. Two factors contributed to the backlog, according to FDA. First, FDA received an unanticipated, heavy volume of breast implant adverse event reports. Second, FDA lacked funds to increase hiring for the former medical device reporting contractor (United States Pharmacopeial Convention, Inc.) that performed data processing functions related to the reports. FDA told us that it recognized the potential impact of the increasing backlog and decided to enter death and serious injury reports immediately, leaving less serious injury and malfunction reports to be entered when resources permitted. FDA also emphasized that it screened the malfunction reports for hazards that required immediate attention and that it believes the public health was not compromised by the backlog.