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Medical Device Tracking

The FDA requires medical device tracking for certain medical devices in the event that a recall is required. A new guidance was released that adds the Thoracic Aortic Aneurism (TAA) stent grafts to the list of devices required to be tracked.

Tracking methods must provide certain critical information about the location of the tracked device within a short time frame. Manufacturers will have 3 days to provide the information about the devices that have not yet been distributed to a patient and 10 working days for devices that were distributed to patients.

Distributors of the devices are also subject to maintaining the required records for medical device tracking and providing such information to the manufacturer of the device upon request. Again, this tracking requirements are only required devices if its failure would be reasonably likely to have serious adverse health consequences, and if that device was either a permanently implantable device or a life-sustaining or life-supporting device used outside a device user facility.

FDA has issued orders to manufacturers who are required to track the following implantable devices:
• Temporomandibular Joint (TMJ) prosthesis
• Glenoid fossa prosthesis
• Mandibular condyle prosthesis
• Implantable pacemaker pulse generator
• Cardiovascular permanent implantable pacemaker electrode
• Replacement heart valve (mechanical only)
• Automatic implantable cardioverter/defibrillator
• Implanted cerebellar stimulator
• Implanted diaphragmatic/phrenic nerve stimulator
• Implantable infusion pumps
• Abdominal Aortic Aneurysm (AAA) stent grafts
• Silicone gel-filled breast implants
• Cultured epidermal autografts
• Thoracic Aortic Aneurysm (TAA) stent grafts

FDA has issued orders to manufacturers who are required to track the following devices that are used outside a device user facility:
• Breathing frequency monitors
• Continuous ventilators
• Ventricular bypass (assist) device
• DC-defibrillators and paddles

FDA has discretion on 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 that comes to the agency’s attention. The following additional guidance factors may be considered to determine whether a tracking order should be issued:
A. likelihood of sudden, catastrophic failure;
B. likelihood of significant adverse clinical outcome; and
C. the need for prompt professional intervention.

The agency may add or remove devices from the list of tracked devices and may consider the additional guidance factors in conjunction with the review of premarket applications, recall data, medical device reporting, inspections, petitions, postmarket surveillance or other information coming to its attention.

The following devices that were subject to tracking orders issued by the agency in February 1998 have received subsequent orders releasing them from mandatory tracking requirements:
• Intraocular Lenses
• Vascular graft prosthesis of less than 6 millimeters diameter
• Vascular graft prosthesis of 6 millimeters and greater diameter
• Interarticular disc prosthesis (interpositional implant)
• Annuloplasty ring
• Tracheal prosthesis
• Arterial stents (used in coronary or peripherial arteries)
• Penile inflatable implant
• Silicone inflatable breast prosthesis
• Testicular prosthesis, silicone gel-filled
• Silicone gel-filled chin prosthesis
• Silicone gel-filled angel chik reflux valve
• Infusion pumps - designated and labeled for use exclusively for fluids with low potential risks, e.g., enteral feeding, anti-infectives.
• Electromechanical infusion pumps
• Dura mater

A copy of the guidance document may be found at: http://www.fda.gov/cdrh/comp/guidance/169.pdf

For more information on this please contact mdi at info@mdiconsultants.com.

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