Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

Need help with how to include medical device kits in GUDID. Do we need UDIs for our kits, or only the individual devices in the kit and a UDI number for the container? Our systems are sold as kits (surgical trays or containers with various Class I instruments, multiple size Class II implants, and/or implant caddies - kit may be for implants, instruments, or combination of both); Replenishment products are sold individually upon request. 

There is a draft January 4, 2016 FDA Guidance on requirements for convenience kits, which it defines as devices that "remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified" before they are used. They do not include implantable devices, or devices that are packed as non-sterile and then repeatedly sterilized. Based on your post, it seems you would need not a UDI for the kit because it is not a "convenience kit.".  All the items in this kit would need a UDI:

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479242.pdf

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Patrick Kager
MedPharma Partners LLC
United States
------------------------------

Original Message:
Sent: 18-Sep-2018 12:22
From: Anonymous Member
Subject: UDI-Medical Device Surgical Kits

This message was posted by a user wishing to remain anonymous

Hello all,

Need help with how to include medical device kits in GUDID. Do we need UDIs for our kits, or only the individual devices in the kit and a UDI number for the container? Our systems are sold as kits (surgical trays or containers with various Class I instruments, multiple size Class II implants, and/or implant caddies - kit may be for implants, instruments, or combination of both); Replenishment products are sold individually upon request. 

It really depends on what you are defining as a "kit" because under the UDI one of the GUDID Data Elements is Kit which is defined as: "Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and are being distributed as a medical device."  This is generally intended that each individual medical device in the kit also has a UDI number especially if they can be sold separately.  Then the kit itself would have a UDI number which would be ​Yes for the GUDID Data Element.  This is probably a bit more complicated then could be addressed in a few lines of text in a forum, suggest reading the Preamble to the Federal Register as FDA talks about kits and what constitutes a kit - especially for implantable surgical procedure kits as these are complicated in of themselves.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-Sep-2018 16:03
From: Patrick Kager
Subject: UDI-Medical Device Surgical Kits

There is a draft January 4, 2016 FDA Guidance on requirements for convenience kits, which it defines as devices that "remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified" before they are used. They do not include implantable devices, or devices that are packed as non-sterile and then repeatedly sterilized. Based on your post, it seems you would need not a UDI for the kit because it is not a "convenience kit.".  All the items in this kit would need a UDI:

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479242.pdf

------------------------------
Patrick Kager
MedPharma Partners LLC
United States

Original Message:
Sent: 18-Sep-2018 12:22
From: Anonymous Member
Subject: UDI-Medical Device Surgical Kits

This message was posted by a user wishing to remain anonymous

Hello all,

Need help with how to include medical device kits in GUDID. Do we need UDIs for our kits, or only the individual devices in the kit and a UDI number for the container? Our systems are sold as kits (surgical trays or containers with various Class I instruments, multiple size Class II implants, and/or implant caddies - kit may be for implants, instruments, or combination of both); Replenishment products are sold individually upon request. 

Following this....We are also in a similar situation.  By definition our kits are not convenience kits. We have surgical trays: sold non-sterile (sterilized at point of use): Implant trays contain multiple size Class II implants and may or may not include Class I instruments; associated instrument trays contain Class I instruments.  Each individual item, including the empty surgical tray and any implant caddies, has UDI number. Items are individually packaged and sold separately for restocking the trays. We have not pursued issuing a UDI number for the stocked trays.

------------------------------
Susan Cochran
Regulatory
USA
------------------------------

Original Message:
Sent: 19-Sep-2018 05:21
From: Richard Vincins
Subject: UDI-Medical Device Surgical Kits

It really depends on what you are defining as a "kit" because under the UDI one of the GUDID Data Elements is Kit which is defined as: "Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and are being distributed as a medical device."  This is generally intended that each individual medical device in the kit also has a UDI number especially if they can be sold separately.  Then the kit itself would have a UDI number which would be ​Yes for the GUDID Data Element.  This is probably a bit more complicated then could be addressed in a few lines of text in a forum, suggest reading the Preamble to the Federal Register as FDA talks about kits and what constitutes a kit - especially for implantable surgical procedure kits as these are complicated in of themselves.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 18-Sep-2018 16:03
From: Patrick Kager
Subject: UDI-Medical Device Surgical Kits

There is a draft January 4, 2016 FDA Guidance on requirements for convenience kits, which it defines as devices that "remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified" before they are used. They do not include implantable devices, or devices that are packed as non-sterile and then repeatedly sterilized. Based on your post, it seems you would need not a UDI for the kit because it is not a "convenience kit.".  All the items in this kit would need a UDI:

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479242.pdf

------------------------------
Patrick Kager
MedPharma Partners LLC
United States

Original Message:
Sent: 18-Sep-2018 12:22
From: Anonymous Member
Subject: UDI-Medical Device Surgical Kits

This message was posted by a user wishing to remain anonymous

Hello all,

Need help with how to include medical device kits in GUDID. Do we need UDIs for our kits, or only the individual devices in the kit and a UDI number for the container? Our systems are sold as kits (surgical trays or containers with various Class I instruments, multiple size Class II implants, and/or implant caddies - kit may be for implants, instruments, or combination of both); Replenishment products are sold individually upon request.