FDA Adds Device to Its Tracking List

Thoracic aortic aneurysm stent grafts have been added to the list of devices subject to tracking requirements, according to a final guidance released last week.

The FDA may require tracking for Class II or III devices for which failure would probably have serious adverse health consequences, that are intended to be implanted for more than one year, that are life-sustaining or supporting and that are used outside a device-user facility.

Devices already listed include implantable pacemaker pulse generators, replacement heart valves (mechanical only) and automatic implantable cardioverter/defibrillators. Devices used outside a device-user facility that require tracking include breathing frequency monitors, continuous ventilators, ventricular bypass (assist) devices and DC defibrillators and paddles.

The FDA can add or remove devices from the list based on statutory requirements or additional guidance factors, the guidance says.

DC defibrillators and implants have specific tracking requirements. Defibrillators must be tracked to the vehicle, craft or organization that purchased the device, but the tracking does not need to be extended to the patient level. Implants must be tracked to the patient level and updated as necessary. If a patient refuses to have a device tracked, a manufacturer is still required to track the device using the product model and serial number.

The guidance can be found at www.fda.gov/cdrh/comp/guidance/169.html.