Postmarket Requirements for Medical Devices: A Practical Guide
41
• 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
A kit or system assembler is considered a distrib-
utor by FDA and, therefore, needs to comply with
the distributor’s tracking requirement. They are
also responsible for ensuring that, when appropri-
ate, anyone who receives the kit or system knows
that it includes a tracked device. The manufactur-
er’s original labeling shall remain on every tracked
device included in the kit or system. Additionally,
initial importer distributors also are responsible
for ensuring the device is traceable throughout
distribution in the US. A foreign manufacturer
may act as its own initial distributor therefore,
foreign manufacturers also are responsible for
medical device tracking. Failure to comply with
the medical device tracking requirements may
result in the imported device being detained at the
US port of entry.
User facilities such as nursing homes and
hospitals act as a final distributor when the
device is for single use and otherwise have
responsibilities as a multiple distributor when the
device is reusable (multiple use). For example, a
hospital that implants single use tracked devices
is the final distributor for that device. A hospital
outpatient clinic that rents, leases, or loans a mul-
tiple use tracked device is the multiple distributor
for that device.
Patients may refuse to provide their per-
sonal information required for device tracking
purposes. The refusal should be documented by
the product, model, and serial number, and the
information provided to the manufacturer. This
required information should be retained by the
manufacturer for the useful life of the device. A
patient’s refusal to provide personal information
does not discharge the manufacturer of its duties
to account for the tracked device.
Any failure to comply with the tracking
regulations, either by the manufacturer or distrib-
utor (including initial importer, final distributor,
or multiple distributor, is considered a violation
of the FD&C Act, and the device will be labeled
as misbranded.
Device tracking is no longer required by
FDA once the manufacturer, importer, or dis-
tributor (including final distributor or multiple
distributors) can confirm:
• The device has been returned, destroyed, or
explanted
• The patient has died
For Class III PMA devices that are subject to
tracking orders, the need for continued tracking
may be reassessed either at the sponsor’s request
or FDA’s initiative, 10 years from the date of the
original PMA approval.
Additional information on the medical
device tracking system, including the current list
of devices to be tracked, can be found on FDA’s
website under 21 CFR 821.
Unique Device Identification
The unique device identification (UDI) system
was established by FDA to adequately trace a
medical device through its distribution and use.
FDA UDI requirements are listed under both 21
CFR 80145 and 21 CFR 830.46
A UDI is a unique numeric or alphanumeric
code that consists of the following:
• Device identifier (DI): The DI is a man-
datory and fixed portion of the device,
critical for the identification of device
(specific device model or version) and its
manufacturer/labeler
• Production identifier (PI): The PI is a
conditional and variable portion of the UDI,
critical for providing traceability of a device
to the patient level. The following informa-
tion, if included on the device label, must
also be included in the PI part of the UDI:
º Device serial number
º Device lot or batch number within
which it was manufactured
º Device expiration date
º Device manufacturing date
º For an HCT/P, a distinct identification
code is required by 21 CFR 1271.290(c)
41
• 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
A kit or system assembler is considered a distrib-
utor by FDA and, therefore, needs to comply with
the distributor’s tracking requirement. They are
also responsible for ensuring that, when appropri-
ate, anyone who receives the kit or system knows
that it includes a tracked device. The manufactur-
er’s original labeling shall remain on every tracked
device included in the kit or system. Additionally,
initial importer distributors also are responsible
for ensuring the device is traceable throughout
distribution in the US. A foreign manufacturer
may act as its own initial distributor therefore,
foreign manufacturers also are responsible for
medical device tracking. Failure to comply with
the medical device tracking requirements may
result in the imported device being detained at the
US port of entry.
User facilities such as nursing homes and
hospitals act as a final distributor when the
device is for single use and otherwise have
responsibilities as a multiple distributor when the
device is reusable (multiple use). For example, a
hospital that implants single use tracked devices
is the final distributor for that device. A hospital
outpatient clinic that rents, leases, or loans a mul-
tiple use tracked device is the multiple distributor
for that device.
Patients may refuse to provide their per-
sonal information required for device tracking
purposes. The refusal should be documented by
the product, model, and serial number, and the
information provided to the manufacturer. This
required information should be retained by the
manufacturer for the useful life of the device. A
patient’s refusal to provide personal information
does not discharge the manufacturer of its duties
to account for the tracked device.
Any failure to comply with the tracking
regulations, either by the manufacturer or distrib-
utor (including initial importer, final distributor,
or multiple distributor, is considered a violation
of the FD&C Act, and the device will be labeled
as misbranded.
Device tracking is no longer required by
FDA once the manufacturer, importer, or dis-
tributor (including final distributor or multiple
distributors) can confirm:
• The device has been returned, destroyed, or
explanted
• The patient has died
For Class III PMA devices that are subject to
tracking orders, the need for continued tracking
may be reassessed either at the sponsor’s request
or FDA’s initiative, 10 years from the date of the
original PMA approval.
Additional information on the medical
device tracking system, including the current list
of devices to be tracked, can be found on FDA’s
website under 21 CFR 821.
Unique Device Identification
The unique device identification (UDI) system
was established by FDA to adequately trace a
medical device through its distribution and use.
FDA UDI requirements are listed under both 21
CFR 80145 and 21 CFR 830.46
A UDI is a unique numeric or alphanumeric
code that consists of the following:
• Device identifier (DI): The DI is a man-
datory and fixed portion of the device,
critical for the identification of device
(specific device model or version) and its
manufacturer/labeler
• Production identifier (PI): The PI is a
conditional and variable portion of the UDI,
critical for providing traceability of a device
to the patient level. The following informa-
tion, if included on the device label, must
also be included in the PI part of the UDI:
º Device serial number
º Device lot or batch number within
which it was manufactured
º Device expiration date
º Device manufacturing date
º For an HCT/P, a distinct identification
code is required by 21 CFR 1271.290(c)