Unique Device Identification: 
Convenience Kits
 
Guidance for Industry and Food and 
Drug Administration Staff 
Document issued on April 26, 2019. 
The draft of this document was issued on January 4, 2016 
For questions about this document regarding CDRH-regulated devices, contact the 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 1-800-335-4709 or 240-402-8010, email: 
ocod@fda.hhs.gov. 
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-4048. 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Guidance@fda.hhs.gov to receive a copy of the draft guidance.  Please use the document number 
1500010 to identify the guidance you are requesting. 
CBER 
Additional copies of this guidance document are also available from the: Center for 
Biologics Evaluation and Research (CBER), Office of Communication, Outreach and 
Development, 10903 New Hampshire Ave, Bldg. 71, Room 3128, Silver Spring, MD 20993, 
or by calling 1-800-835-4709 or 240-402-8010, by email ocod@fda.hhs.gov, or from the 
Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/d
efault.htm.  Contains Nonbinding Recommendations 
Table of Contents 
I. Introduction ........................................................................................................................ 1 
II. Background ........................................................................................................................ 2 
III. Convenience Kits ............................................................................................................... 3 
A. Clarification of Key Concepts ........................................................................................ 3 
B. Examples ........................................................................................................................ 3 
C. Questions and Answers .................................................................................................. 6  Contains Nonbinding Recommendations 
Unique Device Identification: 
Convenience Kits
 
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 
FDAs unique device identification system includes unique device identifier (UDI) labeling 
(21 CFR 801.20) and data submission requirements (21 CFR 830.300).1 The unique device 
identification system regulations require that the label and device package of a device must 
bear a UDI, unless an exception or alternative applies. An exception is provided at 21 CFR 
801.30(a)(11) for devices packaged within the immediate container of a convenience kit, if 
the label of the convenience kit bears a UDI. 
This guidance describes FDAs interpretation of the definition of convenience kit at 21 
CFR 801.3 and as used in 21 CFR 801.30(a)(11).  This guidance does not apply to in vitro 
diagnostic (IVD) devices that are subject to the IVD labeling requirements under 21 CFR 
part 809, nor does it apply to combination products as defined in 21 CFR 3.2(e). 
Terms clarified within this guidance apply only for purposes of this guidance document and 
the UDI regulations, and are not intended to be applied beyond the regulations and policies 
pertaining to the unique device identification system. This guidance does not define the term 
convenience kit for other regulatory purposes.2 Further, this guidance does not suggest that 
                                                          
1 The final rule establishing the unique device identification system was published on September 24, 2013 (78 
FR 58786) (the UDI Rule). See also section 226 of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Public Law 110-85) and section 614 of the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Public Law 112-144), which added and amended section 519(f) of the FD&C Act 
(21 U.S.C.  360i(f)). 
2 The term convenience kit as used in this guidance document is not applicable to the May 20, 1997, guidance 
entitled Convenience Kits Interim Regulatory Guidance 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm). In 
 
1  Contains Nonbinding Recommendations 
compliance with the UDI regulations eliminates the need to comply with any other applicable 
requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act or its implementing 
regulations. 
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 
Evaluation and Research (CBER).  You and your refers to the labeler, as defined in 21 
CFR 801.3. 
FDAs 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 
The unique device identification system was established to adequately identify devices 
through distribution and use.3 The unique device identification system regulations require 
that the label and each device package of every medical device distributed in the United 
States bear a UDI, unless an exception or alternative applies (21 CFR 801.20). 
The term convenience kit is defined in 21 CFR 801.3 as two or more different medical 
devices packaged together for the convenience of the user.  Individual devices packaged 
within the immediate container of a convenience kit are excepted from the UDI labeling 
requirements of 21 CFR 801.20, provided that a UDI is on the label of the immediate 
container of the convenience kit (21 CFR 801.30(a)(11)).  Convenience kits are themselves 
devices.4,5
Although FDA previously expressed thinking that medical procedure kits containing only 
devices are convenience kits,6 FDA believes that this policy requires clarification for 
consistency with the objective of the unique device identification system.7 For purposes of 
                                                          
addition, this guidance does not apply to a medical convenience kit as that term is described in clause xiii of 
21 U.S.C.  360eee(24)(B) or 21 U.S.C.  353(e)(4)(M). 
3See Footnote 1.
4FDA clarified in the UDI Rulethat convenience kits are considered devices. Seethe UDI Rule at 78 FR58792 
(Convenience kits are in wide use and are medical devices in their own right, apart from their constituent 
devices...[C]onveniencekits are by definition devices and therefore are required to meet UDI requirements.).
5Ifyou are uncertain about whether your collection of two or more different devices meets the definition of a 
device atsection 201(h) of the FD&C Act, 21 U.S.C.  321(h), please contact CDRHs Premarket Notification 
(510(k)) Programat 510k_program@fda.hhs.govor CBERs OCOD at ocod@fda.hhs.gov.
6See the UDI Rule at 78 FR 58800.
7 The overarching objective of the unique device identification system regulations, as required by section 519(f) 
of the FD&C Act, is to provide a system to adequately identify medical devices through distribution and use. 
We interpret this to mean that the UDI should be able to identify a device through distribution up to and 
including the point at which the device is used by an end user. The UDIs function of identifying the device 
 
2 Contains Nonbinding Recommendations 
the UDI regulations, FDA does not consider every medical procedure kit, nor every 
collection of two or more medical devices, to be a convenience kit. 
FDA recognizes that the interpretation of terms provided in this guidance may mean that 
fewer medical procedure kits are convenience kits for purposes of the UDI regulations, 
which may impact the assembly and packaging of medical procedure kits that are not 
convenience kits. Nevertheless, FDA believes that the interpretation of the term 
convenience kit in this guidance document is appropriate. As for all devices, a labeler may 
request an exception from or alternative to a UDI requirement under 21 CFR 801.55.8
III.  Convenience Kits
 
A.  Clarification of Key Concepts 
This section provides FDAs interpretation of, and explanatory information about, the terms 
below, for purposes of this guidance and the UDI regulations. 
  Convenience Kit: A convenience kit is two or more different medical devices 
packaged together for the convenience of the user (21 CFR 801.3). FDA interprets 
this to mean a device that contains two or more different medical devices packaged 
together and intended to remain packaged together and not to be replaced, substituted, 
repackaged, sterilized, or otherwise processed or modified before being used by an 
end user. 
  Packaged together: Packaged together means packed (e.g., wrapped or sealed) in a 
single container that is not intended to be unwrapped or unsealed before it is used by 
an end user. 
  End user: The end user is the individual using the device on or on behalf of a patient, 
e.g., the patient, a caregiver, a healthcare practitioner, or a medical technologist. 
  Medical Procedure Kit: A medical procedure kit typically consists of one or more 
medical devices, packaged together to facilitate a single surgical or medical 
procedure.9 A medical procedure kit may be a convenience kit. 
B.  Examples  
                                                          
through distribution and use, among other benefits,facilitates rapid identification of adverse events and more 
efficient management of device recalls.
8 For more information, see 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIExceptio
nsAlternativesandTimeExtensions/default.htm. 
9 See the UDI Rule at 78 FR 58800. 
3 Contains Nonbinding Recommendations 
The following examples illustrate how FDA interprets convenience kit for purposes of 
FDAs unique device identification system requirements, including UDI labeling and data 
submission requirements. 
Example 1: Retail first aid kit 
A first aid kit10 sold at retail that includes only devicessuch as bandages, cold compresses, 
scissors, and an oral thermometerpackaged together is a convenience kit.  It is a device that 
contains two or more different medical devices that are packaged together for the 
convenience of the user and intended to remain packaged together and not to be replaced, 
substituted, repackaged, sterilized, or otherwise processed or modified before being used by 
an end user.  Therefore, the label of each individual device within the container is not 
required to bear a UDI, provided that a UDI is available on the label affixed to the immediate 
container of the kit.  
After purchasing a first aid kit, the end user may choose to replenish devices or add more 
devices over time, rather than purchasing a new first aid kit.  A labeler may choose to market 
individual devices separately to the end user. In such cases, the label and device package of 
the individual devices that may be used to replenish or augment the first aid kit must bear a 
UDI because they are not part of the convenience kit. 
Example 2: Non-sterile orthopedic device set 
A collection of orthopedic devices comprises implants and reusable instruments that are all 
supplied non-sterile.  Each of these devices is removed from its packaging to be placed into a 
sterilization tray11 for cleaning and sterilization at some point prior to use, as intended by the 
labeler.  Only a few of the implants in each set may be selected for implantation in a single 
procedure on a single patient.  After the procedure, the sets are replenished with different 
implants, replacing those used during the procedure.  The sterilization tray, the replacement 
implants, the implants that were in the sterilization tray prior to the procedure and not chosen 
for surgical use, and the reusable instruments, are all sterilized for potential use in subsequent 
surgical cases. This is not a convenience kit because the devices are not intended to remain 
packaged together without undergoing sterilization before being used by an end user.  
Therefore, each device must comply with all applicable UDI labeling, data submission, and 
direct mark requirements.12
                                                          
10 Many first aid kits comprise co-packaged drug and device components and are therefore combination 
products (see 21 CFR 3.2(e)(2)).  As stated earlier, this guidance document does not apply to combination 
products.  Questions about combination products can be directed to combination@fda.hhs.gov. 
11 Although FDA has previously used the terms kits and trays interchangeably (see the UDI Rule at 78 FR 
58800), the term tray may be confusing, as it may refer to an individual device (i.e., sterilization tray) 
separate from the other implants and instruments, or to the collection of implants, instruments and sterilization 
tray, or to a part of the packaging of a sterile medical device.  In this guidance, tray is referring to the 
individual device. 
12 Direct marking requirements only apply to devices that are intended to be used more than once and intended 
to be reprocessed between uses (21 CFR 801.45). The Unique Device Identification: Direct Marking of Devices 
guidance (Direct Mark guidance) is available at 
4 Contains Nonbinding Recommendations 
If these device sets were considered convenience kits for purposes of the UDI regulations, 
the single UDI required for the convenience kit would not differentiate between implants 
used on the patient and those remaining in the sterilization tray.  This would be contrary to 
the objective of the unique device identification system, which is to provide adequate 
identification of medical devices through distribution and use.13
Example 3: Single use disposable medical procedure kit 
A single use, disposable medical procedure kit, such as an anterior cruciate ligament (ACL) 
procedure kit, comprises sterile, single use instruments such as guide wires, drill tip guide 
pins, tunnel plugs, and a graft passer that are used for ACL reconstruction procedures.  The  
kit comprises devices that are packaged and sealed in a single container, and the container is 
supplied sterile.  The container is intended to remain sealed and the contents sterile until the 
contents are about to be used on a patient.  All the devices are used for a single procedure on 
a single patient, or, if unused after a single procedure on a single patient, disposed of without 
being used because sterility has been compromised.  This single use disposable medical 
procedure kit is a convenience kit because it is a device comprising individual devices 
packaged together for the convenience of the user and not intended to be replaced, 
substituted, repackaged, sterilized, or otherwise processed or modified before the devices are 
used by an end user. Therefore, the label of each individual device within the container is not 
required to bear a UDI, provided that a UDI is available on the label affixed to the immediate 
container of the kit.  
This example is distinguishable from Example 2, in which the devices are intended to be 
sterilized prior to use and intended to be reassembled and restocked between uses. 
Example 4: Sterile kit containing both single-use and reusable medical devices packaged 
together 
A suture kit contains single-use sutures and reusable stainless steel instruments, including 
forceps, needle holders, and scissors.  The kit is supplied sterile, but after the initial 
procedure in which the single use device (suture) is consumed, the labeler intends that the 
instruments may be reused on different patients, which requires reprocessing before each 
subsequent use.  This is a convenience kit because the individual devices within the device 
are packaged together for the convenience of the user and not intended to be replaced, 
substituted, repackaged, sterilized, or otherwise processed or modified before the devices are 
used by an end user.  Therefore, the label of each individual device within the container is 
                                                          
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM45
2262.pdf. 
13 See Footnote 7. Additionally, FDA included exceptions to the UDI requirements at 21 CFR 801.30 to make 
the overall UDI system more efficient and to ensure that the burdens imposed by the UDI system are reasonably 
balanced with its benefits. UDI Rule at 78 FR 40749. 
5 Contains Nonbinding Recommendations 
not required to bear a UDI, provided that a UDI is available on the label affixed to the 
immediate container of the kit. 
In this example, some devices in the kit are intended by the labeler to be reprocessed and 
reused, and therefore those reusable devices are subject to direct mark requirements (21 CFR 
801.45).14  
Example 5: Different devices that are packaged together for the convenience of the user but 
the collection of devices is not itself a device 
A labeler manufactures fluid-filled teething rings in a variety of shapes.  The labeler 
packages one teething ring of each shape together as a fixed quantity to create an item for 
retail with a higher profit margin and/or to allow each end user to select and use a particular 
model of teething ring according to preference. This is not a convenience kit because the 
devices packaged together are not collectively a device. 
C.  Questions and Answers 
1.  To be considered a convenience kit for purposes of the UDI 
regulations, should all of the devices within a container be finished 
devices? 
Yes.  We interpret medical devices in the definition of convenience kit in 21 CFR 801.3 
(two or more different medical devices packaged together for the convenience of the user) 
to mean finished devices and not device components.  Finished devices are defined by 21 
CFR 801.3 as any device or accessory to any device that is suitable for use or capable of 
functioning. 
2.  How much variation is allowed for different convenience kits to be 
identified by the same device identifier (DI)?  If I substitute one device for 
another, will the kit need a new DI? 
It is up to the labeler to determine when a change to a particular model or version of device 
results in a new model or version of the device.  Under 21 CFR 830.50, whenever you make 
a change to a device that is required to bear a UDI on its label, and the change results in a 
new version or model, you must assign a new DI to the new version or model.  
3.  If all the devices in a container are not intended to be consumed in 
a single use, or used at the same time, can this be a convenience kit? 
Yes. If devices packaged together otherwise meet the definition of a convenience kit for UDI 
compliance purposes, all of the contents of the kit need not be intended to be consumed in a 
single use or used at the same time in order to be considered a convenience kit.  Example 1, 
above, is a convenience kit despite the fact that all the individual devices may not be
                                                          
14 See Footnote 11. 
6 Contains Nonbinding Recommendations 
intended to be consumed in a single use.  In that example, the devices within the first aid kit 
are intended to remain packaged together and not replaced, substituted, repackaged, 
sterilized, or otherwise processed or modified before initial use by an end user. 
4.  What production identifiers (PIs) must be included in the 
convenience kit UDI? 
The convenience kit is itself a device.  The UDI of the convenience kit must include any PIs 
on the convenience kit label that are required by 21 CFR 801.40(b), unless an exception15 or 
alternative applies.  
5.  If my device meets the UDI labeling exception for a convenience 
kit under 21 CFR 801.30(a)(11), may I still place a UDI on individual 
devices or device labels in the kit? 
Yes, 21 CFR 801.30(a)(11) is an available exception, not a requirement.  You may place 
UDIs on devices or device labels within a convenience kit.  If any individual devices with 
UDIs on the devices or device labels are included in a convenience kit, it may be useful to 
reference the DIs of the individual devices within the device identifier (DI) record for the 
convenience kit that is submitted to the Global Unique Device Identification Database 
(GUDID).  Stakeholders using AccessGUDID,16 the public portal for GUDID, often find it 
useful to know whether or not there will be a label to scan on devices in a kit and to have 
access to the additional information in the DI records of the kit. 
6.  Are there any special rules for creating a DI record in the GUDID 
for a convenience kit? 
For technical recommendations on how to submit information to GUDID, including 
information relating to convenience kits, please visit FDAs website.17
                                                          
15 For example, pursuant to 21 CFR 801.30(d), the UDI of a class I device is not required to include a 
production identifier. 
16 See AccessGUDID available at: https://accessgudid.nlm.nih.gov/. 
17 Available at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm. 
7