Re-selling off-the-shelf (OTS) accessories for medical devices

S

Silvertabb

#1
What are the regualtory and quality requirements for a company to buy off the shelf products such as standard AA batteries, power cables, cables adaptors for USB, etc. from the open market and stocking/selling them for use with their cleared medical devices under each of the following scenariors:

1) Company buys off the shelf product and uses the product Catalogue number in its own inventory tracking system. In this case, the product is not changed in any way.

2) Company buys off the shelf product and create its own Catalogue number in the form of a sticker or equivalent (overlabeling).

3) Company buys off the shelf product and creates another container with the appropriate labeling.

Assumption: all accessories have undergone the required test validation by the OEM and the buyer only performs the verification to demonstrate the accessories are compatible with their medical device.

All above scenario are for FDA.

By the way, is it OK for a company to buy off the shelf product and list itself on the labeling as the distributor?
thanks
 
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M

MIREGMGR

#2
What are the regualtory and quality requirements for a company to buy off the shelf products such as standard AA batteries, power cables, cables adaptors for USB, etc. from the open market and stocking/selling them for use with their cleared medical devices

Assumption: all accessories have undergone the required test validation by the OEM and the buyer only performs the verification to demonstrate the accessories are compatible with their medical device.
Whether such items are US FDA medical devices depends on judgment calls, which should be documented in your QMS, as to their criticality in relation to the classification, risk level and intended use of your primary device(s). I don't know of any clear guidance on the issue. My view would be that disposable batteries for a minimal-risk Class I device probably aren't medical devices, if in the event of a low-battery or dead-battery scenario the patient will not be misdiagnosed or incorrectly treated and the user is made aware in some manner to change the batteries.

under each of the following scenariors:

1) Company buys off the shelf product and uses the product Catalogue number in its own inventory tracking system. In this case, the product is not changed in any way.

2) Company buys off the shelf product and create its own Catalogue number in the form of a sticker or equivalent (overlabeling).

3) Company buys off the shelf product and creates another container with the appropriate labeling.
If you don't want to treat a third party component as a medical device and you're known to your customers as a medical device seller, you definitely don't want to re-label or otherwise establish among your customers the impression that the third party component is a special component that they can only get from you, and that is critical to the functionality of your primary product. That would only be appropriate if you want to take medical device responsibility for the third party component.

You could follow scenario 2 if your sticker was small enough to not cover any essential information on the existing product, and not obscure its manufacturer identification and trade dress.

By the way, is it OK for a company to buy off the shelf product and list itself on the labeling as the distributor?
Sure, in scenario 3 above. Just don't overlabel the product itself, don't attempt to obscure who the product manufacturer is, and make sure that any essential product information from the original packaging is duplicated on your packaging.

Technically, you're a re-seller, not a distributor in the usual legal sense of that word.

If the maker doesn't want you re-selling, they might be able to figure out some way to prevent you from buying. Or, they might sell their product with a "shrink-wrap-agreement", under which the buyer nominally agrees not to use the product in your manner, or in medical devices of any kind. The most likely situation though is that they won't even be aware of you.
 
S

Silvertabb

#3
MIREGMGR
thanks for your input.
We are recommending to use a select number of brands for which we have verification data. I looks like reselling prodcts create some liablity. It seems like in our case input from the following would be needed:
Legal
Purchasing
and
revisit the hazard analysis of the system with which the accessories is going to be used.
Any comments?
 
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