FDA adds device to tracking list
Device Regulation Alert: Safety, Compliance and Reimbursement News, September 1, 2008
The FDA will require device manufacturers to track thoracic aortic aneurysm stent grafts, according to new guidance.
Tracking is intended to facilitate notification and recall if a device presents a serious health risk that requires prompt attention. The FDA may require tracking for Class II or III devices:
- For which failure would probably result in serious adverse health consequences
- That are intended to be implanted for more than one year
- That are life-sustaining or supporting and are used outside a device-user facility
The guidance provides a list of devices that manufacturers must track. The FDA can decide whether to order tracking for devices that meet the statutory requirements or to release devices from tracking based on additional guidance factors and other relevant information.
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