21 CFR Part 821

The point medical device tracking regulation is make sure the FDA, manufacturers, distributors, and patients can track certain devices from the manufacturing to the patient. The main reasons to do this are:

• to ensure we can locate, remove, or notify patients of dangerous or defective devices or serious risks to health.
• to help the FDA and manufacturers to monitor the performance and safety of the devices and to identify and address any potential problems or issues.
• to protects the rights and interests of the patients who have received the devices and ensures that they receive timely and accurate information and assistance.

Which devices are subject to tracking?

The tracking requirements apply to Class II or Class III devices that meet the following criteria:

• The device failure is likely to have serious adverse health consequences. This means that the device failure could cause death, life-threatening injury, permanent impairment, or require medical or surgical intervention to prevent permanent harm.
• The device is intended to be implanted in the human body for more than one year.
• The device is life-supporting or life-sustaining and is used outside a device user facility. This includes devices such as ventilators, infusion pumps, and oxygen concentrators.

The FDA maintains a list of devices that require tracking on its website.

What are the responsibilities of manufacturers?

Manufacturers of tracked devices must comply with the following requirements:

• Establish a procedure for tracking the device throughout its distribution. There must be a way to collect and record the following information:
  • The name and address of the distributor, the date of shipment, the lot number, the serial number, and the expiration date of the device.
  • The name and address of the device user facility, the licensed practitioner who implanted the device, or the patient who received the device.
  • The date of implantation, if applicable, or the date of receipt by the patient.
  • The status of the device, such as whether it is in use, explanted, returned, or disposed of.
• Establish a quality assurance program that includes auditing to verify the accuracy and completeness of the tracking information. The audits must be conducted at least once a year and must include a representative sample of the tracked devices.
• Provide the FDA with the tracking information upon request. The FDA may request the tracking information for any reason, such as to conduct a recall, to investigate a safety issue, or to monitor compliance. The manufacturer must provide the tracking information within 10 working days of the request, unless otherwise specified by the FDA.
• Update the tracking information at least every six months for the useful life of the device. The useful life of the device is the expected duration of the device’s functionality, as determined by the manufacturer. The update must include any changes in the status or location of the device, as well as any corrections or additions to the tracking information.

What are the responsibilities of distributors?

Distributors of tracked devices must cooperate with the manufacturers and the FDA. They must:

• Maintain records of the tracking information provided by the manufacturer. The records must include the information listed above, as well as the date of receipt and the date of shipment of the device, and records of individual patients the device was sold to.
• Provide the manufacturer or the FDA with the tracking information upon request. The distributor must provide the tracking information within 10 working days of the request, unless otherwise specified by the manufacturer or the FDA.
• Provide the patient or the implanting physician with the tracking information upon request. The distributor must provide the tracking information within 10 working days of the request, unless otherwise specified by the patient or the physician.