Discontinuation of a Medical Device

T

thereach

#1
We manufacture a device that is an older technology and doesn't sell very well. The device is safe and effective but we want to discontinue manufacturing it and remove it from the market (if required). We no longer wish to support the devices currently in the field. We have no replacement for the device but can refer our current users to alternative devices from other manufacturers. These devices may be covered by health insurance. Are there any FDA or CMS regulations related to manufacturer requirements when discontinuing manufacture of devices? Would we be required to remove the devices from existing users or simply notify them that the device will no longer be supported?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
We manufacture a device that is an older technology and doesn't sell very well. The device is safe and effective but we want to discontinue manufacturing it and remove it from the market (if required). We no longer wish to support the devices currently in the field. We have no replacement for the device but can refer our current users to alternative devices from other manufacturers. These devices may be covered by health insurance. Are there any FDA or CMS regulations related to manufacturer requirements when discontinuing manufacture of devices? Would we be required to remove the devices from existing users or simply notify them that the device will no longer be supported?
Hi and welcome to the cove :bigwave:

The answer probably depends to some extent on the type of device. A disposable is quite different from capital equipment... An installed / serviced device is different from a user-serviceable or no-service-required hand-held.

I also assume you're not talking about an implant... ;)

Cheers,
Ronen.
 
T

thereach

#3
Thanks Ronen. It's an FDA class II, non implantable, home-use. Not disposable but uses disposable parts. Does this help? I would like to be more explicit but cannot.
 
M

MIREGMGR

#4
I assume your product is in the US, and you're a US company.

I'm not aware of any FDA requirement that limits the ability of a manufacturer to discontinue a product.

There are of course requirements applicable to some products for retention of certain manufacturing and quality records for a period of time related to the "life of the product". I don't think the FDA would accept an arbitrary declaration that the product life had just ended because of a discontinuation decision.

I have no knowledge of CMMS regulations. I can imagine that CMMS might be quite upset at market-discontinuance of a product for which they had recently paid for multiple units, in the actuarial expectation that their expenditures would have a normal service life. Such a withdrawal might leave customers high and dry if their insurance declined to pay for a replacement.

Aside from those considerations, if you have one or more units of product in the field that are within the warranty period that applied at their time of sale, you are unlikely to be able to cease supporting those units of product without exposing yourself to customer civil lawsuit.

One way out of that constraint would be for you to contract with a third party to handle your future warranty obligations. That, however, has hidden risks if the third party drops the ball, because your customers can still come after you legally.

You also could buy out the outstanding warranties, or convince customers to accept an alternate product in place of yours.
 
Last edited by a moderator:

somashekar

Staff member
Super Moderator
#5
You have your right to discontinue your medical device. However kindly look at these possibilities.
1. Warranty support upto your last sold device.
2. Device lifetime that you have considered, and some advisory notice about how you will support post warranty service / disposable supplies (If the disposable parts are also discontinued) through this period
3. Advisory notice on possibility of how a different disposable part could be used on your obsolete device (possibly some adaptors used) that still ensures safe and effective use of your device.
4. Advisory notice about contacts for support that is extended until the lifetime of the last device placed in the market.
 
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