Medical Devices: FDA Can Improve Oversight of Tracking and Recall Systems
HEHS-98-211
Published: Sep 24, 1998. Publicly Released: Oct 28, 1998.
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Highlights
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.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| 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, the Commissioner of FDA should 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. |
Closed – Implemented
FDA has completed revisions to the Compliance Policy Guide. The Guide now includes requirements that inspectors verify the tracking systems of device manufacturers during routine inspections.
|
| 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, the Commissioner of FDA should 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 Congress on the results of its assessment of options for covering the costs of operating a device tracking system for failed establishments. |
Closed – Not Implemented
FDA and the industry do not appear likely to agree on a method of financing this type of effort.
|
| 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, the Commissioner of FDA should 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. |
Closed – Not Implemented
FDA believes that the legal obligation of tracking is continuous.
|
| 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, the Commissioner of FDA should examine the reasons for delays in completing recalls of tracked devices and develop and implement strategies for improving the timeliness of recalls. |
Closed – Implemented
FDA has implemented a new recall process and it has delegated to District Recall Coordinators the authority to classify Class II and III recalls and to submit recall information electronically. A new computer model assists the district office staff in determining the current status of recalls.
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Topics
Consumer protectionManagement information systemsManufacturing industryMedical equipmentMonitoringProduct recallsProduct safetyProsthetic devicesMedical devicesCompliance oversight