Regulatory Open Forum

Hello all, 

My company has a Medical Device that we are discontinuing due to Business decision. I did not see much of the FDA website regarding this. Can you please provide some education what needs to be done in terms of regulatory. Also, the device does not have a expiration date. How long do we need to keep the complaint system open to accommodate users? 

Best, 

SKH

I'm following as we have a device that is not regulated and are considering discontinuing so i would like to see what is said. 

I do know one thing, you say the device does not have an expiry date but does it have an expected lifetime?  I believe that you would need to keep any systems that support that device open for as long as the lifetime of the device.

Hello all, 

My company has a Medical Device that we are discontinuing due to Business decision. I did not see much of the FDA website regarding this. Can you please provide some education what needs to be done in terms of regulatory. Also, the device does not have a expiration date. How long do we need to keep the complaint system open to accommodate users? 

Best, 

SKH

Hello!

Is your company planning to obsolesce the device entirely or would it still be serviced if a device in the field needs technical support? If it is still being serviced, it could be argued that the device is still under "commercial distribution" and hence will have no impact of device registration and listing. If it will not even be serviced anymore, then from an FDA perspective you will need to remove the device from your registration and listing database. Depending on the class of the device, it may have been published to GUDID as well. In which case, you will need to end-date the device in the GUDID database. Other than that, there will be no other "notification" required to FDA.

In terms of complaint handling/record keeping, the requirement is to maintain records for the duration of the "expected life" of the device. The expected life is defined in the design history file as the length of time the device may be expected to remain operational in the field. This is different from "shelf life" which you allude to in your expiration date comment.

Hope this helps!

Manan

Hello all, 

My company has a Medical Device that we are discontinuing due to Business decision. I did not see much of the FDA website regarding this. Can you please provide some education what needs to be done in terms of regulatory. Also, the device does not have a expiration date. How long do we need to keep the complaint system open to accommodate users? 

Best, 

SKH

Sartaj

Full disclosure, I am not familiar with Mr. Lim, but his response is much more comprehensive and addresses the key areas you should focus on with respect to the FDA.  Also, has your device been distributed OUS either through CE, local registrations, or CFG?  If so, you would want to follow the checklist Mr. Lim provided for those areas as well.  The biggest issue is to manage risk after production has ceased.

Larry