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Unique Device Identification: 

Convenience Kits

Final Guidance

Christina Savisaar

Regulatory Policy Analyst

Loretta Chi

Senior Regulatory Counsel

Division of Technical and Data Services

Office of Strategic Partnerships and Technology Innovation

Center for Devices and Radiological Health

U.S. Food and Drug Administration

May 21, 2019
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• Objectives

• Background

• Scope

• Definitions

• Convenience Kits Policy

• Stakeholder Considerations

• Examples

Agenda
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Objectives

• Become familiar with the content of the final guidance document issued on 

April 26, 2019

• Understand the FDA’s interpretation of the definition of convenience kit for 

purposes of unique device identification as it applies to the exception at 21 

CFR 801.30(a)(11) 

• Understand the FDA’s current thinking regarding medical procedure kits as 

convenience kits
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• The objective of the Unique Device Identification system is to adequately 

identify devices through distribution and use to facilitate:

• Rapid identification of adverse events

• More efficient management of recalls

• Reduction in medical errors

• Secure global distribution

Background
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• Regulations require that the label and every device package of every 

medical device distributed in the United States bear a unique device 

identifier (UDI), unless an exception or alternative applies.

• Under 21 CFR 801.30(a)(11), individual devices packaged within the 

immediate container of a convenience kit are excepted from the UDI 

labeling requirements, if a UDI is on the label of the immediate container of 

the convenience kit.

Background
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• The draft guidance on convenience kits published on January 4, 2016.

• In response to comments received on the draft guidance, the FDA narrowed 

the scope of the final guidance and made some clarifications.

• The final guidance on convenience kits published on 

April 26, 2019.

Background
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The Unique Device Identification Convenience Kits final guidance:

• Is not intended to be applied beyond the regulations and policies pertaining 

to the unique device identification system.

• Does not apply to in vitro diagnostic (IVD) devices that are subject to 21 

CFR Part 809.

• Does not apply to combination products as defined in 21 CFR 3.2(e).

Scope
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• Convenience kit is defined in the regulations as “two or more different medical 

devices packaged together for the convenience of the user” (21 CFR 801.3).

• The FDA interprets this to mean a convenience kit is 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.

Convenience Kit
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• Packaged together: Packed (for example, 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: Individual using the device on or on behalf of a patient, for 

example, the patient, a caregiver, a healthcare practitioner, or a medical 

technologist. 

• Medical procedure kit: Typically consists of one or more medical devices, 

packaged together to facilitate a single surgical or medical procedure. A 

medical procedure kit may be a convenience kit.

Additional Definitions
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• The preamble of the UDI final rule expressed thinking that medical procedure 

kits containing two or more devices are “convenience kits.”

• This final guidance clarifies that under our interpretation of the term 

“convenience kit:”

– The FDA does not consider every medical procedure kit to be a 

convenience kit for purposes of UDI regulations.

– The FDA does not consider every collection of two or more medical 

devices to be a convenience kit for purposes of the UDI regulations.

Medical Procedure Kits
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• The exception at 21 CFR 801.30(a)(11) is not mandatory. 

– If a device is a convenience kit, as described in this final guidance, a labeler 

(typically, the manufacturer) may label each device within the kit with a UDI. 

• In submitting convenience kit records to the Global Unique Device Identification 

Database (GUDID), it is helpful to note which devices in the kit, if any, will have 

a label with a UDI that can be scanned and which will not.

If a device is a convenience kit...
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• The FDA recognizes the interpretation of terms provided in this guidance may 

mean fewer medical procedure kits are “convenience kits” for purposes of the 

UDI regulations 

• As for all devices, a labeler may request an alternative to a UDI requirement 

under 21 CFR 801.55, including the policies outlined in this guidance. In 

drafting a request for an alternative, please consider how the alternative will 

achieve the objectives of the Unique Device Identification system.

Stakeholder Considerations
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Example 1: Retail First Aid Kit

A first aid kit sold at retail that includes only devices packaged together:

• containing 2 or more different medical devices 

• 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
Retail First Aid Kit

• A first aid kit sold at retail that includes only devices packaged 

together is a convenience kit. – It is a device 

• containing 2 or more different medical devices 

• 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

– 21 CFR 801.30(a)(11) is applicable

• If a UDI is on the label affixed to the immediate container of the convenience kit, 

then the label of each individual device within the container is not required to bear a 

UDI. 
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• After purchase, the user may choose to replenish or modify the kit.

• A labeler may choose to market individual devices separately to the end user.

– Label/packages of 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. 

Retail First Aid Kit
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Non-sterile orthopedic device set:

• Collection of non-sterile implants and reusable instruments

• Intended by labeler to be placed in sterilization tray for cleaning or sterilization 

before use

• Only a few of the implants are selected for use

• Unselected implants, used instruments, and new implants to replenish those 

used are cleaned and sterilized for potential use in future cases

Example 2: Non-Sterile Orthopedic Device 

Set
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A non-sterile orthopedic device set is not a convenience kit:

– Not intended to remain packaged together without undergoing sterilization 

prior to use.

– Each device must comply with applicable UDI labeling, data submission, and 

direct mark requirements.

Non-Sterile Orthopedic Device Set
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A single use disposable medical procedure kit:

• Comprises different devices that are packaged and sealed in a single 

container, which is supplied sterile

• 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 during that procedure, disposed of 

Example 3: Single Use Disposable Medical 

Procedure Kit
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A single use disposable medical procedure kit is a convenience kit: 

– It is a device 

• containing 2 or more different medical devices 

• 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

– 21 CFR 801.30(a)(11) is applicable

Single Use Disposable Medical Procedure Kit
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A suture kit contains single-use sutures and reusable stainless steel instruments 

and is supplied sterile:

• After the initial procedure in which the suture is consumed, the labeler intends 

that the instruments may be reused on different patients, which requires 

reprocessing before each subsequent use.

Example 4: Sterile kit containing both single-use 

and reusable medical devices packaged together
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This kit is a convenience kit:

• 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.

• Items in the kit intended to be reprocessed and reused are subject to direct 

marking.

Sterile kit containing both single-use and reusable medical 

devices packaged together
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• A labeler packages one teething ring of each (of a number) of models of varied 

shapes together as a fixed quantity to create an item for retail with a higher 

profit margin or to allow each end user to select and use a particular teething 

ring.

Example 5: Different devices that are packaged 

together for the convenience of the user but the 

collection of devices is not itself a device
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• This package is not a convenience kit. 

– Devices packaged together are not collectively a device.

Different devices that are packaged together for the 

convenience of the user but the collection of devices is not 

itself a device
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• UDI Convenience Kit Final Guidance: 

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/unique-device-identification-convenience-kits

• UDI Help Desk: 

www.fda.gov/medical-devices/unique-device-identification-udi/fda-udihelp-desk

Resources
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Questions?

UDI Help Desk: www.fda.gov/udi

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

Slide presentation, transcript, and webinar recording will be 

available at

www.fda.gov/training/cdrhlearn

under heading Unique Device Identification (UDI) System