There were similar difficulties in locating patients who had received a jaw implant device manufactured by Vitek. These responsibilities include providing agency field staff with guidance on inspecting manufacturers for compliance with the regulation during GMP inspections and monitoring corrections and removals of device products from the market. FDA Inspections Do Not Ensure Manufacturers Can Track Devices to End Users

FDA’s approach to ensuring that device manufacturers are operating tracking systems capable of tracing devices from distribution to end users has several limitations, such as a failure to include audits of the tracking systems in its inspections and infrequent inspections. Moreover, FDA has not taken steps to ensure that tracking continues when manufacturers responsible for tracking go out of business, merge, or are acquired by others. However, a senior FDA official told us that this requirement has never been used and is not included in FDA’s guidance manual. In addition, FDA’s inspections of manufacturers’ tracking systems have not been conducted at least once every 2 years, as required by GMP standards. In addition, the Office of Compliance also plans to develop an audit plan that will require FDA inspectors to independently verify the adequacy of manufacturers’ standard operating procedures for tracking and determine whether the procedures are being followed. FDA also did not terminate recalls of tracked devices in a timely manner. Of the 49 recalls that were reported completed by manufacturers, less than one-half were terminated by FDA within its 90-workday standard. Recommendations to the Commissioner of the Food and Drug Administration

To improve FDA’s ability to monitor manufacturer compliance with the medical device tracking regulation and conduct recalls of tracked devices in a timely manner, we recommend that the Commissioner of FDA develop and implement a plan to verify the completeness and accuracy of data in the tracking systems of device manufacturers to ensure that the systems can trace devices through the chain of distribution to end users, take steps to recover the medical device tracking records of manufacturers that have failed and have not provided such information to FDA and report to the Congress on the results of its assessment of options for covering the costs of operating a device tracking system for failed establishments, revise the medical device tracking regulation to require an establishment that acquires the right to manufacture another establishment’s tracked device either through merger or acquisition to immediately notify FDA that it has assumed the tracking obligations of the former establishment, and examine the reasons for delays in completing recalls of tracked devices and develop and implement strategies for improving the timeliness of recalls. To determine the amount of time manufacturers and FDA took to complete recalls of tracked devices, we analyzed data in recall records and FDA’s recall database maintained by CDRH and the Office of Regulatory Affairs on the dispositions of 54 recalls of tracked devices that were initiated by manufacturers during fiscal years 1994 through 1996. FDA guidelines instruct manufacturers to complete recalls within 6 months from the date of initiation of the recall.
Why GAO Did This Study

Pursuant to a congressional request, GAO provided information on whether the Food and Drug Administration (FDA) is providing adequate oversight of the tracking systems of high-risk device manufacturers and whether recalls of devices are executed promptly, focusing on whether: (1) FDA ensures that manufacturers operate tracking systems that are capable of tracking devices through the distribution chain to end users; and (2) device manufacturers and FDA are executing recalls of tracked devices in a timely manner.

What GAO Found

GAO noted that: (1) there are several weaknesses in FDA's approach for determining whether device manufacturers are operating tracking systems capable of quickly locating and removing defective devices from the market and notifying patients who use them; (2) FDA's inspections of the tracking systems do not include independent audits that could verify the completeness and accuracy of data in the systems; (3) instead, the inspections focus on reviews of the manufacturers' written standard operating procedures for tracking; (4) further, although the good manufactured product standard require FDA to inspect manufacturers of tracked devices at least once every 2 years, only about one-half of the 238 manufacturers subject to tracking were inspected during fiscal year (FY) 1996 and FY 1997; (5) FDA attributed its limited inspection activity to a reduction in field resources; (6) FDA has also not acted to ensure that device tracking continues when establishments go out of business, merge, or are acquired by other entities; (7) FDA officials told GAO they are planning to revise their inspection program to include an audit plan to better assess manufacturers' compliance with the tracking requirements and redirect FDA's compliance priorities toward high-risk devices, such as implant devices; (8) the details for most of these plans, however, have not yet been determined; (9) in GAO's analysis of FDA's recall data, manufacturers and FDA have not acted in a timely manner to correct and remove defective devices from the market; (10) less than one-third of the 54 recalls initiated from FY 1994 through FY 1996 were completed by manufacturers within 6 months, as specified in FDA guidelines; (11) FDA has also had problems terminating device recalls in a timely manner; (12) less than one-half of the 49 recalls reported completed by manufacturers were reviewed and terminated by FDA within the 90-workday standard established by the agency; and (13) FDA officials have identified several factors that may contribute to delays in completing recalls, but an in-depth review of the recall procedures used by manufacturers and FDA has not been conducted.