Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
40
ventilators, ventricular bypass devices, and
DC-defibrillators and paddles, etc.
The objective of this guidance document was
three-fold:
• To ensure that the device is traceable in
commercial distribution, i.e., from the
manufacturing site through the distribution
channel (distributors, user facilities, licensed
practitioners, etc.) to the person for whom
the device is intended (the patient)
• To ensure manufacturers can expeditiously
remove a defective or potentially defective
device from the market
• Effective device tracking is required to
facilitate patient notification or device recall
if necessary
Tracking records should be retained for the
useful life of the device, which is defined as “the
time of the device is in use or in distribution for
use under 21 CFR 821.60.”42
The primary responsibility for device tracking lies
with the device manufacturer however, any other
person, including the device importer or distribu-
tor, also are responsible for ensuring a functional
device tracking system. Details of manufacturer
requirements and additional requirements are
listed below:
Manufacturer Requirements
Under 21 CFR 821.25,43 a manufacturer is
required to establish a written standard operating
procedure (SOP) for tracking requirements for
medical devices, including implantable devices.
The SOP outlines the process for the collection,
maintenance, and auditing of tracking data for
medical devices meeting the tracking criteria listed
above. A method of tracking must provide critical
information about the tracked device’s location
within a short period of time. The required critical
information should include the following:43
• Device identification (UDI, lot number,
model number, batch number etc.)
• Device shipping date
• The date the device was provided to the
patient
• Patient details (name, address, phone num-
ber, social security number)
• Prescribing physician details (name, address,
and phone number)
• If applicable, the date the device was
explanted from the patient and returned to
the manufacturer
The timeline to submit the critical information to
FDA is listed below:43
• Manufacturers will have three working days
to provide the required critical information
to FDA for devices that have not been dis-
tributed to the patient yet.
• Manufacturers will have ten working days to
provide the required critical information to
FDA for devices that have been distributed
to patients or implanted in a patient
To ensure the tracking system is effective, a
manufacturer shall conduct audits at six-month
intervals for the first three years after receiving
tracking orders and for at least annually there-
after. Tracking systems are also subject to FDA
inspection to confirm that the method is effective
in tracking the device to the end user.
Additional Tracking Requirements
In addition to the manufacturer, distributors,
including final distributors or multiple distrib-
utors, of any tracked device should be able to
ensure that the primary manufacturer can locate
a device if needed and provide the primary
manufacturer with the following information for
tracking a device in order to stay compliant with
the medical device tracking requirements under
21 CFR 821.30.44
• Details of the distributor, final distributor, or
multiple distributors
• Device identification (UDI, lot number,
model number, batch number, etc.)
• Device shipping date
• The date the device was provided to the
patient
Chapter 2: Postmarket Compliance: US
40
ventilators, ventricular bypass devices, and
DC-defibrillators and paddles, etc.
The objective of this guidance document was
three-fold:
• To ensure that the device is traceable in
commercial distribution, i.e., from the
manufacturing site through the distribution
channel (distributors, user facilities, licensed
practitioners, etc.) to the person for whom
the device is intended (the patient)
• To ensure manufacturers can expeditiously
remove a defective or potentially defective
device from the market
• Effective device tracking is required to
facilitate patient notification or device recall
if necessary
Tracking records should be retained for the
useful life of the device, which is defined as “the
time of the device is in use or in distribution for
use under 21 CFR 821.60.”42
The primary responsibility for device tracking lies
with the device manufacturer however, any other
person, including the device importer or distribu-
tor, also are responsible for ensuring a functional
device tracking system. Details of manufacturer
requirements and additional requirements are
listed below:
Manufacturer Requirements
Under 21 CFR 821.25,43 a manufacturer is
required to establish a written standard operating
procedure (SOP) for tracking requirements for
medical devices, including implantable devices.
The SOP outlines the process for the collection,
maintenance, and auditing of tracking data for
medical devices meeting the tracking criteria listed
above. A method of tracking must provide critical
information about the tracked device’s location
within a short period of time. The required critical
information should include the following:43
• Device identification (UDI, lot number,
model number, batch number etc.)
• Device shipping date
• The date the device was provided to the
patient
• Patient details (name, address, phone num-
ber, social security number)
• Prescribing physician details (name, address,
and phone number)
• If applicable, the date the device was
explanted from the patient and returned to
the manufacturer
The timeline to submit the critical information to
FDA is listed below:43
• Manufacturers will have three working days
to provide the required critical information
to FDA for devices that have not been dis-
tributed to the patient yet.
• Manufacturers will have ten working days to
provide the required critical information to
FDA for devices that have been distributed
to patients or implanted in a patient
To ensure the tracking system is effective, a
manufacturer shall conduct audits at six-month
intervals for the first three years after receiving
tracking orders and for at least annually there-
after. Tracking systems are also subject to FDA
inspection to confirm that the method is effective
in tracking the device to the end user.
Additional Tracking Requirements
In addition to the manufacturer, distributors,
including final distributors or multiple distrib-
utors, of any tracked device should be able to
ensure that the primary manufacturer can locate
a device if needed and provide the primary
manufacturer with the following information for
tracking a device in order to stay compliant with
the medical device tracking requirements under
21 CFR 821.30.44
• Details of the distributor, final distributor, or
multiple distributors
• Device identification (UDI, lot number,
model number, batch number, etc.)
• Device shipping date
• The date the device was provided to the
patient