Instructions for Use - Quantity Requirements (20 Pouches to a Box)

Q

QM Becky

#1
Good Morning Everyone,
Hope all are well. I'm in a debate with my marketing guy and my operations guy over instructions for use and the quantity we need to include in the box.

The product is a prescription only Class II medical device, sold sterile, disposable (single use), individually pouched, 20 pouches to a box. Not CE marked (the CE marked question is later). Currently only 2 IFUs are included in the box.

Contention 1: 2 is adequate, and no more are needed. Doctors know how to use the device.

Contention 2: 2 is not adequate, you don't know the experience level of the user on the other end, and regardless, if we are providing IFUs then the use is not inherently obvious.

The questions is,... are either of these contentions more right than the other, and how many IFUs should/shall be included?

I'm coming up short on guidance from anyone on quantity requirements or recommendations.

Same question then applies to CE marked products. Their IFU is a booklet that has the required translations, but the question of quantity remains the same.

Anyone have any thoughts?

Thansk!

QM Becky
 
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Q

QM Becky

#3
That's a good point, if 20 aren't required, then why any number other than 1. This is a product we brought in house during a recent acquisition, and the previous company used 2. For the immediate term, we aren't changing anything, but we are reviewing all aspects to determine if there are things we can/should. This is one of them. Really, the definition of "adequate" as related to quantity is what I'm looking for.

My concern is that these are placed into an inventory warehouse at the hospital or stocking distributor and maybe they are all used by the same person and maybe they are not... in the case of not, are we obligated to supply enough for a 1:1 ratio? my previous employer, said yes... this one, questioning my judgement. I will admit I'm a bit more conservative... but now I want to push for specific references if there are any.
 
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