Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016

TempusVernumProcella

Starting to get Involved
#1
HELP - :bonk:

There is a heated discussion underway at work whether or not a product document stating the instructions for use (product insert/IFU) is required to be placed in each primary packaged (non-sterile) IVD box/bag - OR - If they can place an IFU in each Shipping container level instead.
My CEO is asking if it is required through FDA to have the IFU in each pkg level or if we just need to put it in the entire shipping box.

Example: our primary pkg level for some products is 10 units per 1 bag, that 1 pack of 10 is then put into a higher pkg level (50's 100's, etc.) and shipped.

My research says that we don't "NEED" an insert in every 10pk bag, but our procedures state that we do. He is asking if it's 'required' through ISO or FDA to put 1 IFU in each 10pk bag.


Sorry if that was confusing - any insight helps! :thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
HELP - :bonk:

There is a heated discussion underway at work whether or not a product document stating the instructions for use (product insert/IFU) is required to be placed in each primary packaged (non-sterile) IVD box/bag - OR - If they can place an IFU in each Shipping container level instead.
My CEO is asking if it is required through FDA to have the IFU in each pkg level or if we just need to put it in the entire shipping box.

Example: our primary pkg level for some products is 10 units per 1 bag, that 1 pack of 10 is then put into a higher pkg level (50's 100's, etc.) and shipped.

My research says that we don't "NEED" an insert in every 10pk bag, but our procedures state that we do. He is asking if it's 'required' through ISO or FDA to put 1 IFU in each 10pk bag.


Sorry if that was confusing - any insight helps! :thanx:
For sure you do while your procedure says so. Both FDA and ISO require that your operations be in compliance with your documented and released procedures.
 

somashekar

Staff member
Super Moderator
#3
HELP - :bonk:

There is a heated discussion underway at work whether or not a product document stating the instructions for use (product insert/IFU) is required to be placed in each primary packaged (non-sterile) IVD box/bag - OR - If they can place an IFU in each Shipping container level instead.
My CEO is asking if it is required through FDA to have the IFU in each pkg level or if we just need to put it in the entire shipping box.

Example: our primary pkg level for some products is 10 units per 1 bag, that 1 pack of 10 is then put into a higher pkg level (50's 100's, etc.) and shipped.

My research says that we don't "NEED" an insert in every 10pk bag, but our procedures state that we do. He is asking if it's 'required' through ISO or FDA to put 1 IFU in each 10pk bag.


Sorry if that was confusing - any insight helps! :thanx:
How do you sell to the end user .. say a hospital.
A bag of 10 and multiples of it.. ?
Then one IFU in every bag of 10 meets the purpose. Your IFU and your shipping packaging are not related.
 
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