Regulatory Open Forum

​​Does anyone know the requirement (if any) for listing the contents of a kit on the packaging label?

For example:  If a kit contains two or three medical devices but are packaged together, does the description on the label stating "XYZ Field Dressing Kit" satisfy the requirement or does it additionally need to list: 1 package of 50 adhesive strips; 10 tongue depressors; etc.

Thanks in advance!

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Cari Reil
Regulatory Affairs/Quality Assurance Manager
Monaghan Medical Corp
Plattsburgh NY
United States
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We always have been told it needs to be the latter - specific contents - though the "title" of the product can be XYZ Kit." Though I couldn't cite you the specific regs offhand for each geography. The rationale being that what I might call an "XYZ Kit" and what you might call an "XYZ Kit" might not contain the same items, so it should be clear to the end user what it actually contains.

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 10-Jan-2018 14:05
From: Cari Reil
Subject: Convenience Kit Labeling

​​Does anyone know the requirement (if any) for listing the contents of a kit on the packaging label?

For example:  If a kit contains two or three medical devices but are packaged together, does the description on the label stating "XYZ Field Dressing Kit" satisfy the requirement or does it additionally need to list: 1 package of 50 adhesive strips; 10 tongue depressors; etc.

Thanks in advance!

------------------------------
Cari Reil
Regulatory Affairs/Quality Assurance Manager
Monaghan Medical Corp
Plattsburgh NY
United States
------------------------------

​Thanks for your reply, much appreciated.  This kit if for the US only.

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Cari Reil
Regulatory Affairs/Quality Assurance Manager
Monaghan Medical Corp
Plattsburgh NY
United States
------------------------------

Original Message:
Sent: 11-Jan-2018 12:07
From: Ginger Glaser
Subject: Convenience Kit Labeling

We always have been told it needs to be the latter - specific contents - though the "title" of the product can be XYZ Kit." Though I couldn't cite you the specific regs offhand for each geography. The rationale being that what I might call an "XYZ Kit" and what you might call an "XYZ Kit" might not contain the same items, so it should be clear to the end user what it actually contains.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 10-Jan-2018 14:05
From: Cari Reil
Subject: Convenience Kit Labeling

​​Does anyone know the requirement (if any) for listing the contents of a kit on the packaging label?

For example:  If a kit contains two or three medical devices but are packaged together, does the description on the label stating "XYZ Field Dressing Kit" satisfy the requirement or does it additionally need to list: 1 package of 50 adhesive strips; 10 tongue depressors; etc.

Thanks in advance!

------------------------------
Cari Reil
Regulatory Affairs/Quality Assurance Manager
Monaghan Medical Corp
Plattsburgh NY
United States
------------------------------