Regulatory Open Forum

Hello,

Which packaging standard should I follow for class II non sterile ( Band ) device? Do I need to include any packaging validation in 510(K)?

Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Bhupinder,

If your Class II device is non-sterile, then there is not any specific standard to follow.  ISO 11607 series can be used for packaging validation though is typically used for sterile devices to show packaging will maintain the sterility through life of the product.  You could theoretically use this standard as well showing packaging maintains integrity.

Now typically packaging for a 510(k) submission of a non-sterile device relies on the transport, shipping, and handling validation (which also should be done for sterile devices as well).  This means that once the product is packaged into its box/carton, then placed in the shipping container, you could follow ASTM D4169 or ISTA guidelines for doing tests such as drop, crush, impact, etc.  You can also consider environmental conditions if this is applicable to your product as well - such as some products are sensitive to temperature and/or humidity.  Shipping and transport validation can be done yourself - such as shipping to a location far away and back - or Fedex and other independent companies provides this service as well.

My own experience is for non-sterile devices, providing shipping, transport, and handling validation of packaging/shipping container removes many questions by FDA reviewer, especially if the finished device may be impacted by shipping and handling.

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

Original Message:
Sent: 22-Jan-2018 16:36
From: Bhupinder Singh
Subject: Packaging Requirements for Class II Device

Hello,

Which packaging standard should I follow for class II non sterile ( Band ) device? Do I need to include any packaging validation in 510(K)?

Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Thanks Richard,

Appreciate your time!

Bhupinder

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Original Message:
Sent: 23-Jan-2018 08:25
From: Richard Vincins
Subject: Packaging Requirements for Class II Device

Bhupinder,

If your Class II device is non-sterile, then there is not any specific standard to follow.  ISO 11607 series can be used for packaging validation though is typically used for sterile devices to show packaging will maintain the sterility through life of the product.  You could theoretically use this standard as well showing packaging maintains integrity.

Now typically packaging for a 510(k) submission of a non-sterile device relies on the transport, shipping, and handling validation (which also should be done for sterile devices as well).  This means that once the product is packaged into its box/carton, then placed in the shipping container, you could follow ASTM D4169 or ISTA guidelines for doing tests such as drop, crush, impact, etc.  You can also consider environmental conditions if this is applicable to your product as well - such as some products are sensitive to temperature and/or humidity.  Shipping and transport validation can be done yourself - such as shipping to a location far away and back - or Fedex and other independent companies provides this service as well.

My own experience is for non-sterile devices, providing shipping, transport, and handling validation of packaging/shipping container removes many questions by FDA reviewer, especially if the finished device may be impacted by shipping and handling.

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

Original Message:
Sent: 22-Jan-2018 16:36
From: Bhupinder Singh
Subject: Packaging Requirements for Class II Device

Hello,

Which packaging standard should I follow for class II non sterile ( Band ) device? Do I need to include any packaging validation in 510(K)?

Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------