Distribution of OBL Product - Does this constitute manufacturing?

M

MJW66

#1
We have a Supplier where we distribute their medical device branded with our name such as "Manufactured for MY COMPANY" We have been having an issue with part of the product in that we have been losing battery life because it has been activated at the manufacturer and due to handling and storage, sometimes the device's timed life has been depleted prior to usage by the customer. A suggestion has been offered whereby my company would activate the battery prior to sending it out to our customers, thus lessening the chance for early battery/device depletion. If we decided to pursue this route, the actual steps for my company would be 1. tear open the sealed plastic bag to access the device 2. activate the battery by turning on a switch on the device 3. applying a label over the switch to prevent customers from switching on/off the battery (the label contains some verbiage) 4. resealing the plastic bag that contains the device.

This is a class I device and it is not a sterile. Do the steps above constitute "manufacturing?" Would my company now be playing a role in the contract manufacture of this finished device? Would all of these steps need a DHR? Or, could we simply classify this as an activation of the product and be excluded as playing any actual manufacturing role? Thanks in advance.
 
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T

treesei

#2
Re: Does this constitute manufacturing?

May be in a gray area but it is easy to consider "activation" a step of manufacturing because "activation" now seems to be a requirement and part of the specs (swtich is at ON position = spec 1; label is on switch = spec 2; the label itself = spec 3) of the device. Since this "activation" occurred before the commercial distribution of the finished device, the manufacturer (your company per label) is fully responsible for this action. Shortened battery life may be related to the safety and performance of the device, depending on the intended use and operative conditions of the device.

Why not just let the contract manufacturer (supplier) do it? You don't have to open and close the bag which seems redundant. There will be no gray area.
 
M

MJW66

#3
Re: Does this constitute manufacturing?

We were trying to lessen the effects of shipping and handling on the activation of the device prematurely. It's a pressure sensitive device and once activated, applying a certain amount of pressure on this device starts the clock counting down. Activating the device at my company right before sale would theoretically lessen the chance of premature counting down of the device's timed life. That is, now that chance is only during the shipment between my company and the end user.
 

somashekar

Staff member
Super Moderator
#4
Re: Does this constitute manufacturing?

We have a Supplier where we distribute their medical device branded with our name such as "Manufactured for MY COMPANY" We have been having an issue with part of the product in that we have been losing battery life because it has been activated at the manufacturer and due to handling and storage, sometimes the device's timed life has been depleted prior to usage by the customer. A suggestion has been offered whereby my company would activate the battery prior to sending it out to our customers, thus lessening the chance for early battery/device depletion. If we decided to pursue this route, the actual steps for my company would be 1. tear open the sealed plastic bag to access the device 2. activate the battery by turning on a switch on the device 3. applying a label over the switch to prevent customers from switching on/off the battery (the label contains some verbiage) 4. resealing the plastic bag that contains the device.

This is a class I device and it is not a sterile. Do the steps above constitute "manufacturing?" Would my company now be playing a role in the contract manufacture of this finished device? Would all of these steps need a DHR? Or, could we simply classify this as an activation of the product and be excluded as playing any actual manufacturing role? Thanks in advance.
You are already the manufacturer, and so doing this bit is only your convenience. You will add your details to the device supplier's DHR which I hope you get it to your control.
 
M

MJW66

#5
Re: Does this constitute manufacturing?

You are already the manufacturer, and so doing this bit is only your convenience. You will add your details to the device supplier's DHR which I hope you get it to your control.

Distributing a device does not constitute manufacturing with respect to 21CFR in the USA. The "gray" area I am referring to in my above question muddies the waters. That is why I am seeking additional opinions before making a decision.
 

somashekar

Staff member
Super Moderator
#6
Re: Does this constitute manufacturing?

Distributing a device does not constitute manufacturing with respect to 21CFR in the USA. The "gray" area I am referring to in my above question muddies the waters. That is why I am seeking additional opinions before making a decision.
When your device label says "Manufactured for MY COMPANY", MY COMPANY is manufacturing, and the "Supplier" where we (you) distribute their medical device, is not in the frame of regulatory picture.
 
M

MJW66

#7
Re: Does this constitute manufacturing?

When your device label says "Manufactured for MY COMPANY", MY COMPANY is manufacturing, and the "Supplier" where we (you) distribute their medical device, is not in the frame of regulatory picture.

That is not correct: As per 21CFR801.1

(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts.
 
S

sjared

#8
If you were to implement this procedure and if for some reason product made it to the customer without the battery activation steps, what would happen? Would your firm now be responsible for the quality of the device in this respect? If so, how are you not now also the manufacturer?
 
M

MJW66

#9
If you were to implement this procedure and if for some reason product made it to the customer without the battery activation steps, what would happen? Would your firm now be responsible for the quality of the device in this respect? If so, how are you not now also the manufacturer?

I tend to agree that if we chose to perform those steps that we would be intimately involved in some portion of completion of the device. My only question is; does this constitute "manufacturing" from a regulatory compliance perspective? I agree it is a gray area. I'm just seeking opinions. I would like to see someone offer a credible reason, if one exists, why it would not be considered manufacturing.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Apart from the battery activation, your company would also be applying a label and repackaging (resealing the plastic bag). I don't see how this would not be considered manufacturing. The only way to avoid it would be by getting a ruling from the FDA :(
 
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