Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the agency to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.
• Devices Subject to Tracking
• Tracking Documents
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Manufacturers must adopt a method of tracking devices whose failure would be reasonably likely to have serious, adverse health consequences; or which is intended to be implanted in the human body for more than one year; or are life-sustaining or life-supporting devices used outside of a device user facility. The regulations implementing the tracking requirements became effective on August 29, 1993 and can be found in 21 CFR Part 821.
Important Note: Effective, February 19, 1998, the tracking requirement has been changed to eliminate automatic mandatory tracking for certain devices. The Modernization Act gives FDA discretion to order manufacturers of certain types of Class II or Class III devices to initiate a program to track their medical devices down to the patient level.
Information on implementation of the Medical Device Tracking Regulation along with the current list of devices that FDA has ordered to be tracked can be found in the following guidance "Guidance on Medical Device Tracking". Please note that 21 CFR 821 does not contain the current list of devices to be tracked. The current list can be found in the guidance document referenced above and at the bottom of this page.
The tracking provision is intended to ensure that manufacturers can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems.
Tracking augments FDA's authority to order mandatory recalls and require notification of health professionals and patients regarding unreasonable risk of substantial harm associated with a device.
Manufacturers of a tracked device must establish a written standard operating procedure (SOP) which includes a method for tracking the device throughout distribution and a quality assurance program including audit procedures. Final distributors of these devices will be required to provide manufacturers with patient information.
Device tracking is required for the useful life of the device.
The types of devices subject to a tracking order may include any Class II or Class III device:
• the failure of which would be reasonably likely to have serious adverse health consequences;
• which is intended to be implanted in the human body for more than one year; or
• which is intended to be a life sustaining or life supporting device used outside a device user facility.
The Modernization Act also allows patients receiving a tracked device to refuse to release, or refuse permission to release, their name, address, social security number, or other identifying information for the purpose of tracking. The FDA plans to contact manufacturers of devices that have previously been identified as devices subject to tracking to indicate whether they should continue to track these devices or if tracking may be discontinued. Manufacturers currently required to track devices under Section 519(e) of the FFD&C Act should not discontinue tracking prior to communication from FDA.
Devices Subject to Tracking
FDA has issued orders to manufacturers who are required to track the following implantable devices:
• Glenoid Fossa prosthesis
• Mandibular condyle prosthesis
• Temporomandibular Joint (TMJ) prosthesis
• Abdominal Aortic Aneurysm Stent Grafts
• Automatic implantable cardioverter/defibrillator
• Cardiovascular permanent implantable pacemaker electrode
• Implantable pacemaker pulse generator
• Replacement heart valve (mechanical only)
• Implanted cerebellar stimulator
• Implanted diaphragmatic/phrenic nerve stimulator
• Implantable infusion pumps
• Silicone Gel-Filled Breast Implants
• Cultured Epidermal Autografts
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
• DC-defibrillators and paddles
• Ventricular Bypass (assist) Device
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