Contains Nonbinding Recommendations 
 
Unique Device Identification: 
Direct Marking of Devices 
Guidance for Industry and  
Food and Drug Administration Staff  
 
Document issued on November 17, 2017.  
The draft of this document was issued on June 26, 2015. 
 
 
 
 
 
 
 
 
For questions about this document regarding CDRH-regulated devices, contact UDI 
Regulatory Policy Support, 301-796-5995; email: GUDIDsupport@fda.hhs.gov. 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach and Development (OCOD) at 1-800-835-4709 or 240-402-8010. 
       U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research 
  Contains Nonbinding Recommendations 
 
Preface 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov .  Submit written comments to the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852.  Identify all comments with the docket number FDA-2015-D-2254. Comments may not 
be acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
CDRH
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance.  Please use the document 
number 1400031 to identify the guidance you are requesting. 
 
CBER
Additional copies are available from the Center for Biologics Evaluation and Research 
(CBER) by written request, Office of Communication, Outreach, and Development (OCOD) 
10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by  
calling 1-800-835-4709 or 240-402-7800, by email, ocod@fda.hhs.gov or from the Internet 
at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/G
uidances/default.htm.    Contains Nonbinding Recommendations 
 
Table of Contents 
I.  Introduction....................................................................................................................................................1
II.  Background................................................................................................................................................2
III. Questions and Answers..............................................................................................................................3
A.  Direct Marking.......................................................................................................................................3
1.  What is direct marking? ..........................................................................................................................3
2.  Which devices are required to be directly marked?................................................................................3
3.  What are the compliance dates for the direct marking requirements?....................................................3
4.  What about a device that has been manufactured and labeled prior to its UDI compliance date? ..........4
5.  Does FDA specify a method to directly mark a device? .........................................................................5
6.  For currently legally marketed devices, does affixing a permanent marking on the device to comply
with UDI requirements require a premarket approval (PMA) supplement, a biologics license application 
(BLA) supplement, or a new premarket notification (510(k)) submission? ...................................................5
7.  If a PMA supplement, BLA supplement, or new 510(k) is required as a result of UDI direct marking
requirements, are user fees also required? ......................................................................................................6
8.  What are the GUDID data submission requirements for devices that must be directly marked with a
UDI? ...............................................................................................................................................................6
9.            What are the recordkeeping requirements for devices that must be directly marked with a UDI?..7
10.  May a labeler voluntarily comply with UDI direct marking requirements? ........................................8
B.  UDI Format............................................................................................................................................8
1.  Is the full UDI required to be directly marked on the device?................................................................8
2.  Does the UDI directly marked on the device need to be identical to the UDI on the device label?........9
3.  For a UDI direct marking, are both the easily readable plain-text and AIDC forms required? ...............9
4.  If a labeler makes a change to a device that requires assigning a new UDI, must the labeler add to or 
replace the existing UDI direct mark? ............................................................................................................9
C.  Reprocessing ........................................................................................................................................ 10
1.  How is intended to be used more than once defined for purposes of UDI direct marking? .............. 10
2.  What does FDA consider intended to be reprocessed for the purposes of UDI direct marking? ...... 10
D.  Exceptions to Direct Marking ............................................................................................................... 11
1.  What exceptions are there to the UDI direct marking requirements? ................................................... 11
2.  Does a non-UDI direct marking (such as the name of the company or part or catalog number) on a 
device itself meet the UDI direct marking requirements? ............................................................................ 12
3.  What is the process for making use of a 21 CFR 801.45(d) ................................................................. 12
4.  What is the process for requesting a specific alternative to direct marking?  How do I request an 
exception from or alternative to the direct marking requirements? .............................................................. 12 Contains Nonbinding Recommendations 
 
 
 
Unique Device Identification:   
Direct Marking of Devices 
 
 
Guidance for Industry and  
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page.  
 
I.  Introduction 
This document will assist industry, particularly labelers, as defined under 21 CFR 801.3, and 
FDA staff in understanding FDAs requirements for direct marking of devices for unique 
device identification purposes.  Under 21 CFR 801.45, [a] device that must bear a unique 
device identifier (UDI) on its label must also bear a permanent marking providing the UDI 
on the device itself if the device is intended to be used more than once and intended to be 
reprocessed before each use. This guidance defines some terms used in the Agencys 
regulations pertaining to the UDI direct marking requirements, including how FDA 
interprets the term intended to be reprocessed as used in 21 CFR 801.45.  For additional 
background on the UDI system, see the Unique Device Identification System Final Rule, 
published on September 24, 2013 (78 FR 58786) (the UDI Rule - 
https://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf ). 
Throughout this guidance document, the terms we, us and our refer to FDA staff 
from the Center for Devices and Radiological Health (CDRH) and the Center for Biologics 
  1 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
Evaluation and Research (CBER).  You and your refers to the labeler, as that term is 
defined in 21 CFR 801.3. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidance means that 
something is suggested or recommended, but not required.   
II.  Background 
Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), 
121 Stat. 854, and Section 614 of the Food and Drug Administration Safety and 
Innovation Act (FDASIA), 126 Stat. 1061, amended the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) to add section 519(f) (21 U.S.C. 360i(f)), which directs FDA 
to issue regulations establishing a unique device identification system for medical 
devices along with implementation timeframes for certain medical devices. The UDI 
Rule, establishing the unique device identification system, was published on September 
24, 2013 (78 FR 58786). It requires that the label and each device package of a medical 
device distributed in the United States bear a UDI, unless an exception or alternative 
applies.  The UDI regulations also require specified information to be submitted to 
FDAs Global Unique Device Identification Database (GUDID).  Most of the 
information submitted to GUDID is available to the public through AccessGUDID at 
https://accessgudid.nlm.nih.gov/. 
The UDI system seeks to improve the identification of medical devices by making it 
possible to rapidly and definitively identify a device and certain key attributes that 
affect its safe and effective use.  This will facilitate more accurate reporting of adverse 
events by making it easier to pinpoint the device at issue in the submitted report.  FDA, 
health care providers, and industry may then more rapidly and precisely extract useful 
information from adverse event reports and thereby gain a better understanding of the 
underlying problems and improve the ability to take appropriate and better-focused 
corrective action. 
For devices required to bear a UDI on their device label, the UDI regulation at 21 CFR 
801.45 requires a UDI direct marking on a device if the device is intended to be used 
more than once and intended to be reprocessed before each use.  As explained in the 
preamble of the UDI Rule, direct marking requirements apply to devices that are 
intended to be used for months or years, sometimes many years.  Because such devices 
are intended to be reprocessed and reused, they will inevitably be separated from their 
  2 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
original labels and device packages.  Direct marking helps to ensure the adequate 
identification of such devices through their distribution and use.  However, the UDI Rule 
does not define intended to be used more than once or intended to be reprocessed.  
FDAs interpretation of these terms as they are used in 21 CFR 801.45 is included in this 
document. 
III.  Questions and Answers 
A.  Direct Marking 
1.  What is direct marking? 
Direct marking, for purposes of UDI requirements, is affixing a UDI permanently on the 
device itself. 
2.  Which devices are required to be directly marked? 
Under 21 CFR 801.45(a), if a UDI is required on a device label, that device is also required 
to have a UDI permanently affixed to the device itself if the device is intended to be used 
more than once and intended to be reprocessed before each use.  This requirement applies to 
all device classes, except class I devices that bear a Universal Product Code (UPC) on their 
label and device packages, as provided in 21 CFR 801.40(d).  As explained in the preamble 
of the UDI Rule, direct marking requirements apply to devices that are intended to be used 
for months or years, sometimes many years. Because such devices are intended to be 
reprocessed and reused, they will inevitably be separated from their original labels and 
device packages. Direct marking helps to ensure the adequate identification of such 
devices. 
 
3.  What are the compliance dates for the direct marking 
requirements? 
The compliance date, i.e., the date by which labelers must comply with the UDI direct 
marking requirements, unless an exception or alternative applies, is based on the device 
category as shown below.  The compliance dates for UDI direct marking requirements 
  3 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
are listed below and also on the UDI webpage1:   
 
Direct Mark  Category of Device Intended to be Reused and Reprocessed 
Compliance Date 
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 
 
4.  What about a device that has been manufactured and labeled prior 
to its UDI compliance date? 
Under 21 CFR 801.30(a)(1), a finished device manufactured and labeled prior to its 
compliance date for 21 CFR 801.20 is excepted from UDI labeling requirements until three 
years after the UDI compliance date for 21 CFR 801.20 for that particular device.  Because 
direct marking requirements and GUDID data submission requirements are tied to the UDI 
labeling requirement at 21 CFR 801.20, the exception at 21 CFR 801.30(a)(1) applies to these 
requirements as well.   
For devices intended to be used more than once and intended to be reprocessed before each 
use, the expiration of the three-year exception under 21 CFR 803.30(a)(1) is still based on the 
compliance date for UDI labeling requirements under 21 CFR 801.20, not the direct marking 
compliance date.  For example, the compliance date for 21 CFR 801.20 for class II devices 
that are not implantable, life-supporting, or life-sustaining was September 24, 2016.  Thus, an 
individual class II device manufactured and labeled on May 1, 2016, that is not implantable, life-
supporting, or life-sustaining and that requires direct marking, would not be required to be in 
compliance with UDI labeling, GUDID data submission, or direct marking requirements 
until September 24, 2019.   
FDA recognizes that some devices are consigned or loaned to hospitals or other healthcare 
facilities prior to the applicable UDI compliance date for 21 CFR 801.20 or are with a sales 
                                                           
 
1 See 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Complianced
atesforUDIRequirements/default.htm. 
  4 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
representative in the field pending sale prior to that UDI compliance date.  To the extent 
those devices are required to comply with UDI regulatory requirements for labeling under 21 
CFR 801.20, direct marking under 21 CFR 801.45, or date format requirements under 21 
CFR 801.18, FDA does not intend to enforce compliance with such requirements for those 
devices. 
5.  Does FDA specify a method to directly mark a device? 
No.  We expect the direct mark UDI to comply with the requirements of 21 CFR 801.45(b) 
and (c) and last throughout the expected service life of the device, taking into account 
expected usage and reprocessing according to the instructions of the manufacturer.  Possible 
methods to directly mark a device with a UDI include etching, attaching a permanent plaque 
to durable equipment, or affixing a permanent tag such as a radio frequency identification 
(RFID) tag to the device.  In some cases, particularly with certain durable equipment, a 
labeler will attach to the device hardware exterior a sticker or some other item that displays 
information and is designed to last the expected service life of the device.  If this item bears 
the UDI in accordance with 21 CFR 801.45(b) and (c), you have fulfilled the requirements of 
21 CFR 801.45.   
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. Moreover, technological advancements may lead to change in 
device usage, methods of device marking, and reprocessing procedures.  The labeler should 
determine the appropriate method to provide such a marking on the device itself.   
6.  For currently legally marketed devices, does affixing a permanent 
marking on the device to comply with UDI requirements require a 
premarket approval (PMA) supplement, a biologics license application 
(BLA) supplement, or a new premarket notification (510(k)) submission? 
The FDA expects labelers to conduct analysis and/or testing to determine the effect of direct 
marking on the safety and effectiveness of the device and to document the basis for such 
determination in the design history file (DHF). If any type of direct marking would 
interfere with the safety or effectiveness of the device, the device would qualify for the 
exception under 21 CFR 801.45(d)(1), and FDA encourages labelers to make use of this 
exception if it applies.  
For devices granted marketing authorization through the De Novo classification process or 
cleared in a 510(k) submission, if any type of direct marking would interfere with the safety 
or effectiveness of the device but the labeler still wishes to directly mark the device, thereby 
not making use of the exception under 21 CFR 801.45(d)(1), clearance of a new 510(k) 
  5 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
submission would likely be required, since FDA anticipates that a direct marking that would 
interfere with the safety or effectiveness of a device for purposes of 21 CFR 801.45(d)(1) 
also could significantly affect the safety or effectiveness of the device under 21 CFR 
807.81(a)(3)(i). When in doubt, FDA encourages labelers to contact the CDRH or CBER 
review division relevant to the device to discuss the specific situation. 
For devices approved in a PMA or BLA, if adding a UDI direct marking would affect the 
safety or effectiveness of the device, this will typically require a PMA or BLA 
supplement under 21 CFR 814.39 or 601.12. If, however, adding a UDI direct marking 
to a device approved in a PMA or BLA would not be expected to affect safety and 
effectiveness, no supplement would be required, but the basis for your determination 
should be documented, and this change should be reported in an annual report.  For 
PMA devices, please review the guidance, Modifications to Devices Subject to 
Premarket Approval (PMA) - The PMA Supplement Decision at 
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/u
cm089274.htm.  For BLA devices, please review the guidance, Changes to an Approved 
Application: Biological Products at 
http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryin
formation/guidances/blood/ucm170166.pdf.  
 
 
7.  If a PMA supplement, BLA supplement, or new 510(k) is required 
as a result of UDI direct marking requirements, are user fees also 
required? 
Yes.  You must pay the applicable user fee, if any, if you submit a PMA supplement, a BLA 
supplement, or a new 510(k) submission.  There are no user fee waivers for submitting a 
PMA supplement, a BLA supplement, or a new 510(k) submission as a result of UDI direct 
marking requirements.  However, FDA encourages you to bundle your required submissions 
rather than submit individually, which will reduce both administrative and user fee burdens. 
See FDA guidance entitled Bundling Multiple Devices or Multiple Indications in a Single 
Submission issued on June 22, 2007 (Bundling Guidance  
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm089731.htm). 
 
8.  What are the GUDID data submission requirements for devices 
that must be directly marked with a UDI? 
  6 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
The UDI regulation at 21 CFR 830.310 sets forth the information submission requirements 
for all devices required to bear a UDI on their label.  If a device is required to be directly 
marked, additional data submission to GUDID may be required.  Under 21 CFR 
830.310(b)(1), the device identifier (DI) 2  portion of the UDI assigned to the version or 
model of the device must be submitted to GUDID.  The DI that must be submitted under 
21 CFR 830.310(b)(1) is the DI included in the lowest level of device packaging required 
to include the full UDI. We refer to this as the Primary DI for purposes of this guidance.  
In addition, if the Primary DI and the DI of the direct mark UDI are different, you need to 
indicate this in GUDID per 21 CFR 830.310(b)(3).3  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.  We outline the 
general exceptions to the UDI direct marking requirements in section III.D of this 
guidance. 
 
 
9.            What are the recordkeeping requirements for devices that must 
be directly marked with a UDI? 
The recordkeeping requirements under 21 CFR 830.360 apply to the UDI on the device 
label, the UDIs on the packages, and the direct mark UDI.  Labelers are required to retain, 
and make available to FDA upon request, records showing all UDIs used to identify devices 
that must bear a UDI on their label.  See 21 CFR 830.360(a).  FDA expects that the records 
will indicate whether a device is directly marked and, if so, whether the direct mark DI is 
the same as or different from the primary DI.  The records should be updated when changes 
to the production identifiers (PIs) are made, in order to reflect all PIs currently associated 
with each DI.  Further, the Device Master Record (DMR) must include, or refer to the 
location of, the DI for the particular version or model of the device, as well as the 
associated types of PIs (i.e., lot or batch, serial number, expiration date, manufacturing 
date, distinct identification code) included in the UDIs for that particular version or 
                                                           
 
2 A unique device identifier is composed of a device identifier and a production identifier, as defined in 21 CFR 
801.3. 
3 For additional information, see Global Unique Device Identification Database (GUDID): Guidance for 
Industry and FDA Staff 
(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM36
9248.pdf) 
  7 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
model of the device.  See 21 CFR 820.181.  The DMR does not need to contain the 
actual PIs.  By contrast, the Device History Record (DHR) must include, or refer to the 
location of, the full UDI (DI and PIs) used to identify the device.  See 21 CFR 820.184. 
If a labelers device falls within one of the exceptions from direct marking under 21 CFR 
801.45(d) and the labeler decides to make use of such exception, the labeler is required to 
keep records supporting this decision in the DHF (see 21 CFR 801.45(e)).  If the labeler 
determines any type of direct marking would interfere with the safety or effectiveness of the 
device (21 CFR 801.45(d)(1)), FDA expects the rationale that supports the decision to be 
scientifically justified by analysis and/or testing and to be documented in the DHF. If the 
device cannot be directly marked because it is not technologically feasible (21 CFR 
801.45(d)(2)), FDA expects the labeler to document the rationale for the technological 
infeasibility in the DHF.  Because it is expected that direct marking technology will 
advance over time, exceptions under 21 CFR 801.45(d)(1) and 21 CFR 801.45(d)(2) may 
lose their applicability over time and thus labelers should periodically reassess their use of 
those exceptions. 
10.  May a labeler voluntarily comply with UDI direct marking 
requirements? 
Yes. FDA encourages affixing a UDI permanently on devices even when not required. If a 
labeler of a device that is not required to bear a UDI as a permanent marking under 21 CFR 
801.45 directly marks such a device voluntarily, or marks it before the compliance date of 
UDI direct marking requirements, GUDID data submission requirements applicable to UDI 
direct marking would also be voluntary but encouraged. (Note that such GUDID data 
submission requirements would no longer be voluntary as of the compliance date for UDI 
direct marking requirements).  Please see sections III.A.6. and 7. above regarding potential 
impact on safety and effectiveness and the potential requirement for an additional premarket 
submission in conjunction with applying a UDI direct marking to a currently marketed 
device. 
 
B.  UDI Format 
 
1.  Is the full UDI required to be directly marked on the device? 
Yes. In general, UDI direct marking must include both the DI and PI portions of the UDI 
See 21 CFR 801.40(b) and 801.45.  Note that PIs are not required in UDIs of class I devices 
per 21 CFR 801.30(d).  Also note that class I devices that bear a UPC on their label and 
  8 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
device packages are not required to comply with UDI direct marking requirements. See 21 
CFR 801.40(d). 
2.  Does the UDI directly marked on the device need to be identical to 
the UDI on the device label? 
No.  Under 21 CFR 801.45(b), the labeler may choose to directly mark the device with a 
UDI identical to the UDI that appears on the label of the device, or with a different UDI to 
distinguish the unpackaged device from any device package containing the device.  As 
explained in the preamble to the UDI Rule the direct mark must provide the full UDI, 
, 
including all the production identifiers that appear on the device label (78 FR 58804).  
However, in situations where a production identifier (e.g., the lot number that appears on 
the device label) 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 production identifier. 
3.  For a UDI direct marking, are both the easily readable plain-text 
and AIDC forms required? 
No.  Unlike the UDI on labels and packages, under 21 CFR 801.45(c), when a device must 
bear a UDI direct marking, the UDI may be provided through either or both of the following: 
(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. 
This permits flexibility given the wide disparity in the physical characteristics of medical 
devices.  In deciding whether to use the easily readable plain-text or the AIDC form or both 
forms of the UDI for direct marking, labelers should consider factors such as technological 
feasibility, efficiency for the end user and risk of human error.  Both the easily readable 
plain-text and the AIDC forms of the directly marked UDI should adhere to the UDI format 
specified by the FDA-Accredited Issuing Agency. See 21 CFR 830.20 and UDI Formats by 
FDA-Accredited Issuing Agency (January 27, 2017) (UDI Formats -
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDe
viceIdentification/UDIIssuingAgencies/UCM489869.pdf.) 
4.  If a labeler makes a change to a device that requires assigning a 
new UDI, must the labeler add to or replace the existing UDI direct 
mark? 
No.  Under 21 CFR 801.45(d)(4), a device that has previously been directly marked in 
compliance with 21 CFR 801.45(a) does not require a new or additional UDI direct mark.  
However, regardless of whether the device is directly marked with a UDI, whenever there 
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is a change to the device that results in a new version or model of the device, a new DI 
must be assigned to the device.  See 21 CFR 830.50(a).  That changed device must bear a 
UDI containing that new DI on its label.  See 21 CFR 801.20.   
As noted above, for example, a labeler may attach to a devices exterior hardware a sticker, 
plaque, or other item that displays information (including the UDI) and fulfills UDI direct 
marking requirements under 801.45.  If the labeler subsequently makes a change to that 
device in the field and the change results in a new version or model, 21 CFR 830.50(a) 
requires a new DI to be assigned to the modified device.  Under 21 CFR 801.20, the label of 
the new version or model of the device  must bear a UDI incorporating that new DI, unless 
an exception or alternative applies.  One way to fulfill these requirements under 21 CFR 
801.20 and 21 CFR 830.50 would be to replace the sticker, plaque, or other item on the 
device hardware with a similar item that bears the new UDI; the labeler could also request 
an exception or alternative. 
 
C.  Reprocessing 
1.  How is intended to be used more than once defined for purposes 
of UDI direct marking? 
For the purposes of the UDI direct marking requirements, under 21 CFR 801.45, "intended to 
be used more than once" means intended for repeated uses on or by different patients, e.g., 
where a device is cleared or approved and labeled 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. 
2.  What does FDA consider intended to be reprocessed for the 
purposes of UDI direct marking? 
 
For purposes of UDI direct marking requirements, 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.  This means that devices that are only intended to be cleaned 
and/or to undergo lower levels of disinfection without subsequent high-level disinfection4 or 
                                                           
 
4 For purposes of this guidance document, high-level disinfection is a lethal process utilizing a sterilant under 
less than sterilizing conditions.  The process kills all forms of microbial life except for large numbers of 
bacterial spores.  
  10 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
 
sterilization before each use or between uses are not required to be directly marked with a 
UDI under 21 CFR 801.45.   
 
D.  Exceptions to Direct Marking 
 
1.  What exceptions are there to the UDI direct marking 
requirements? 
There are four UDI direct marking exceptions outlined in 21 CFR 801.45(d).  The 
requirement of 21 CFR 801.45(a) does not apply to any device that meets any of the 
following criteria: 
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 under 21 CFR 801.45(a). 
A single-use device means a device that is intended for one use, or on a single patient 
during a single procedure. Section 201(ll) of the FD&C Act (21 U.S.C. 321(ll)). FDA 
interprets 21 CFR 801.45(d)(3) to mean that the UDI direct marking requirements do not 
apply to a device that the original labeler (as defined in 21 CFR 801.3) intends for one use, or 
use on a single patient during a single procedure, even if, subsequent to its initial use, the 
device is subjected to additional processing and manufacturing for the purpose of an 
additional single use on another patient. However, such reuse of a single-use device would 
generally require additional clearance or approval unless 510(k)-exempt,5 as well as 
compliance with general UDI labeling and GUDID data submission requirements by the 
entity performing the additional processing and manufacturing for the purpose of an 
additional single use.  In contrast, for purposes of UDI direct marking requirements under 21 
CFR 801.45, a device intended for repeated use on or by different patients is intended to be 
                                                           
 
5 See section 510(o) of the FD&C Act (21 U.S.C. 360(o)) and Medical Device User Fee and Modernization 
Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use 
Medical Devices 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071434.htm) 
regarding 510(k) submissions for reprocessed single-use devices. 
  11 
 
 
 
 
 
 
 
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used more than once and is thus subject to UDI direct marking requirements (see section 
III.C.1). 
Please note that a reprocessed and/or relabeled single-use device must comply with the 
general UDI labeling and GUDID data submission requirements. See definition of labeler 
under 21 CFR 801.3 and requirements for when a device is relabeled under 21 CFR 830.60. 
2.  Does a non-UDI direct marking (such as the name of the company 
or part or catalog number) on a device itself meet the UDI direct marking 
requirements? 
No.  The name of the company or part/catalog number alone does not meet the UDI direct 
marking requirements under 21 CFR 801.45.  If your device design has been cleared or 
approved with a non-UDI direct marking, a justification for an exception under 21 CFR 
801.45(d)(1) or under 21 CFR 801.45(d)(2) should explain how the UDI direct marking and 
the non-UDI direct marking are relevantly different.  For example, a justification for an 
exception under 21 CFR 801.45(d)(1) that UDI direct marking would interfere with the 
safety or effectiveness of the device would explain why the UDI direct mark is different 
than the non-UDI direct marks with respect to its effect on the safety and effectiveness 
of the device. In addition, while 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).  For new 
devices, UDI direct marking requirements should be considered and/or incorporated at 
design inception.  
3.  What is the process for making use of a 21 CFR 801.45(d) 
exception from a direct marking requirement? 
As discussed in III.A.9., under 21 CFR 801.45(e), a labeler who decides that an exception 
under 21 CFR 801.45(d) applies to its device must document the basis of that decision in the 
DHF required by 21 CFR 820.30(j). As explained in III.A.8., in your GUDID data 
submission, you should indicate that the device is subject to direct marking but excepted.  
4.  What is the process for requesting a specific alternative to direct 
marking?  How do I request an exception from or alternative to the direct 
marking requirements? 
The UDI regulation at 21 CFR 801.55 outlines the process for requesting a specific 
alternative to any UDI requirement, including direct marking, by submitting a request to 
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FDA.  Under 21 CFR 801.55(c), FDA may grant an alternative to UDI direct marking or 
any other UDI labeling requirement, 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. 
Please note that there is no reason to submit a 21 CFR 801.55 request for exception from 
UDI direct marking requirements if any exception under 21 CFR 801.45(d) is applicable. 
Requests for the current instructions on requesting an alternative may be submitted using the 
online form by clicking the FDA UDI Help Desk link at  www.fda.gov/udi. 
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