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November 30, 2017 Webinar
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Unique Device Identification: 

Direct Marking of Devices 

Final Guidance

Christina Savisaar, PhD

Regulatory Policy Analyst

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

November 30, 2017 CDRH Webinar www.fda.gov
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Agenda

• Background

• Scope

• Key changes from draft to final guidance

• Highlights from the guidance

• Questions

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Background

• UDI Final Rule September 24, 2013 [78 FR 

58786]

• Intent of the Unique Device Identification 

System is to adequately identify devices through 

distribution and use

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Background

• Unique Device Identification System Requirements 

(unless an exception or alternative applies):

– Device label and device packages must bear a unique 

device identifier (UDI).

– Labeler must submit product information to the Global 

Unique Device Identification Database (GUDID).

– UDI must be directly marked on the device itself if the 

device is intended to be used more than once and 

intended to be reprocessed before each use.

www.fda.gov
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Background

• Draft guidance published on June 26, 2015

• Questions in Notice of Availability

1) Should the definition of ‘‘reprocessing’’ for purposes of UDI 

direct marking requirements include cleaning alone without 

subsequent disinfection and/or sterilization of the device?

2) What public health benefits would be served by requiring a UDI 

direct marking to be affixed to devices intended to be reused 

for which reprocessing instructions include cleaning only and 

not disinfection and/or sterilization?

• Received 17 sets of comments

• Final guidance published on November 17, 2017

www.fda.gov
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Scope of the Guidance

• Applies to devices required to bear a UDI on 

their label that are also:

– Intended to be used more than once, and;

– Intended to be reprocessed.

• Does not apply to implants, which are not 

required to be directly marked.

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Key Changes from the Draft

• Narrows the definition of “intended to be reprocessed” 

for purposes of UDI direct marking

– Draft guidance: we consider a device that is intended to be 

cleaned and either sterilized or disinfected before each use 

to be intended to be reprocessed.

• Does not include a device intended only to be cleaned between uses.

– Final guidance: we consider a device intended to be 

reprocessed if it is intended to undergo high-level 

disinfection and/or sterilization before each use or between 

uses.

• Does not include a device intended only to be cleaned and/or to 

undergo lower levels of disinfection without subsequent high-level 

disinfection or sterilization before each use or between uses.

www.fda.gov
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Key Changes from the Draft

Consigned or loaned devices

To the extent these devices are required to comply with UDI 

requirements, FDA does not intend to enforce compliance 

with labeling under 21 CFR 801.20, direct marking under 21 

CFR 801.45, or date format requirements under 21 CFR 

801.18, for:

– Devices consigned or loaned to hospitals or other health care 

facilities prior to the applicable UDI label compliance date.

– Devices with a sales representative in the field pending sale 

prior to the applicable UDI label compliance date. 

www.fda.gov
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Highlights: Compliance Dates

** FDA issued a letter noting our intent to extend the UDI compliance dates for class I and 

unclassified devices. For more information see: 

https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM561575.pdf

www.fda.gov

UDI Direct 

Mark

Compliance 

Date

Category of Device Intended to be Reused and 

Reprocessed

9/24/2015 Life-sustaining and life-supporting devices, regardless 

of device class

9/24/2016 Class III devices and devices licensed under the Public 

Health Service Act

9/24/2018 Class II devices

9/24/2020 Class I and unclassified devices**
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Highlights: Format of the UDI

• The direct mark should include the device identifier (DI) 

and production identifier (PI) portions of the UDI (all PI 

that appear on the label). Exceptions:

– Class I devices not required to include PI.

– In situations where a PI was unknown at the time a device 

was directly marked during the manufacturing process, FDA 

does not intend to enforce the requirement that the UDI 

directly marked on the device include that PI.

• The UDI directly marked on the device may be the same 

as the UDI on the label, or the labeler may choose a 

different UDI to distinguish the unpackaged device from 

any device package containing the device.

www.fda.gov
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Highlights: Form of the UDI

• Unlike the UDI on labels and packages, the UDI 

direct mark may be provided through either or 

both:

1) easily readable plain-text, or

2) automatic identification and data capture (AIDC) 

technology, or any alternative technology that will 

provide the UDI of the device on demand.

• In deciding the form(s) of the UDI for direct 

marking, labelers should consider factors such as 

technological feasibility, efficiency for the end user 

and risk of human error

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Highlights: Method of Marking

• We expect the direct mark UDI to last throughout the 

expected service life of the device, taking into account 

expected usage and reprocessing according to the 

instructions of the manufacturer.

• We do not specify any particular approach to directly 

mark devices, because it would be difficult to account for 

the wide variety of existing devices, use conditions, and 

reprocessing methods for these devices.

• Technological advancements may lead to change in 

device usage, methods of device marking, and 

reprocessing procedures.

www.fda.gov
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Highlights: GUDID Data Submission

• The DI portion of the UDI assigned to the version or model of 

the device must be submitted to GUDID. This DI is the DI 

included on the lowest level of device packaging required to 

include the full UDI (“Primary DI”).

• If a device is required to be directly marked, additional data 

submission to GUDID may be required: 

– If the Primary DI and the DI of the direct mark UDI are different, 

you need to indicate this in GUDID. However, if the two DIs are 

identical, no additional information needs to be submitted to 

GUDID. 

 

• If you are applying one of the exceptions listed in 21 CFR 

801.45(d), you should indicate in GUDID that the device is 

subject to direct marking but excepted.

www.fda.gov
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Highlights: Voluntary Marking

• If a device is not required to be directly marked 

with a UDI, FDA encourages voluntary direct 

marking, including voluntary GUDID data 

submission requirements applicable to UDI 

direct marking.

www.fda.gov
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Highlights: Reuse

• For the purposes of the UDI direct marking 

requirements, "intended to be used more than 

once" means intended for repeated uses on or 

by different patients.

• If the device is intended to be used more than 

once on or by the same patient, and not on or 

by multiple patients, then the device does not 

need to be directly marked with a UDI.

www.fda.gov
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Highlights: Reprocessing

• For purposes of UDI direct marking, we consider a 

device intended to be reprocessed if it is intended 

to undergo high-level disinfection and/or 

sterilization before each use or between uses.

 

• Devices that are only intended to be cleaned 

and/or to undergo lower levels of disinfection 

without subsequent high-level disinfection or 

sterilization before each use or between uses are 

not required to be directly marked with a UDI.

www.fda.gov
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Highlights: Exceptions

• Exceptions under 801.45(d):

1. Any type of direct marking would interfere with 

the safety or effectiveness of the device;

2. The device cannot be directly marked because it is 

not technologically feasible;

3. The device is a single-use device and is subjected 

to additional processing and manufacturing for the 

purpose of an additional single use; or

4. The device has been previously marked with a UDI 

under 21 CFR 801.45(a).

www.fda.gov
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Highlights: Exception Documentation

• For a labeler to make use of an exception provided 

under 801.45(d):

1. Basis of the decision must be documented in the 

Design History File (DHF);

2. GUDID record for the device should indicate that the 

device is subject to direct marking but excepted;

3. If the exception is based on technological infeasibility, 

plan for periodic reconsideration of applicability since the 

threshold for technological infeasibility may change over 

time with new technology.

www.fda.gov
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Highlights: Non-UDI Markings

• The name of the company or part/catalog number alone 

does not meet the UDI direct marking requirements 

under 21 CFR 801.45.

• The presence of non-UDI direct marking will typically not 

be sufficient justification for an exception under 21 CFR 

801.45(d)(2) on the grounds of limited space.

• Non-UDI direct marking that takes up all available space 

and is required for patient safety could be a justification 

for an exception under 21 CFR 801.45(d)(1).

www.fda.gov
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Highlights: Alternatives

• 21 CFR 801.55 outlines the process for requesting a 

specific alternative to any UDI requirement, 

including direct marking, by submitting a request to 

FDA.

 

• Under 21 CFR 801.55(c), FDA may grant an 

alternative if we determine that:

(a) An alternative would provide for more 

accurate, precise, or rapid device identification; or

(b) An alternative would better ensure the safety 

or effectiveness of the device.

www.fda.gov
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Questions?

FDA UDI Help Desk: www.fda.gov/udi

Subject: UDI Direct Mark Guidance 

General questions about this webinar?

Contact Division of Industry and Consumer Education: DICE@fda.hhs.gov 

Slide presentation, transcript and webinar recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Unique Device Identification (UDI) System

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