Regulatory Open Forum

Hello RAPS team, 

We are class I (self declared) medical devices manufacturer (non sterile, non measuring) and selling devices in US.

2 Years ago, we decided to discontinue of the model and introduced new model in replacement thus stopped selling that model 2 years ago.

In our user and dealer manual, we do provide warranty of chairs 2 years only.
However, our clients can still use product after 2 years by keeping an eye on wear & tear and getting replacement of damaged parts.

We mentioned device expected lifetime 10+ years in our device device specifications.

What do you suggest  me, should we keep that model in listing as device expected lifetime 10+ years and I believe, few ender users are still using that devices.

I know, we can put expiry date in GUDID database but not in the FDA listing.

As per my understanding, we need to remove that models from FDA device listings and put expiry date in front  of that model in GUDID instead of deleting from GUDID. 

Would appreciate your feedback,

Thanks 

Hello Anon.

First you should have an "end of life" plan for the medical device product(s) defining warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.  When there is a medical device which can be used for many years, it is important to define an end of life plan for those products as there are many things which can and must continue even after stop selling.  You are correct there is an expiry data in the GUDID which is entered - refer back to the end of life plan.  For the Medical Device Listing, this should be deactivated at the point the product is no longer sold.  There is not a reason to keep this active.  In fact, you want to deactivate this because when FDA reviews this as part of an inspection they need to understand what products are being actively sold and which are not.

Hello RAPS team, 

We are class I (self declared) medical devices manufacturer (non sterile, non measuring) and selling devices in US.

2 Years ago, we decided to discontinue of the model and introduced new model in replacement thus stopped selling that model 2 years ago.

In our user and dealer manual, we do provide warranty of chairs 2 years only.
However, our clients can still use product after 2 years by keeping an eye on wear & tear and getting replacement of damaged parts.

We mentioned device expected lifetime 10+ years in our device device specifications.

What do you suggest  me, should we keep that model in listing as device expected lifetime 10+ years and I believe, few ender users are still using that devices.

I know, we can put expiry date in GUDID database but not in the FDA listing.

As per my understanding, we need to remove that models from FDA device listings and put expiry date in front  of that model in GUDID instead of deleting from GUDID. 

Would appreciate your feedback,

Thanks 

Hello Richard,

Thanks for your prompt help. 

Could you please share FDA guidelines to document 'end of life' plan?
Do you have any template?

Thanks 

Hello Anon.

First you should have an "end of life" plan for the medical device product(s) defining warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.  When there is a medical device which can be used for many years, it is important to define an end of life plan for those products as there are many things which can and must continue even after stop selling.  You are correct there is an expiry data in the GUDID which is entered - refer back to the end of life plan.  For the Medical Device Listing, this should be deactivated at the point the product is no longer sold.  There is not a reason to keep this active.  In fact, you want to deactivate this because when FDA reviews this as part of an inspection they need to understand what products are being actively sold and which are not.

Hello RAPS team, 

We are class I (self declared) medical devices manufacturer (non sterile, non measuring) and selling devices in US.

2 Years ago, we decided to discontinue of the model and introduced new model in replacement thus stopped selling that model 2 years ago.

In our user and dealer manual, we do provide warranty of chairs 2 years only.
However, our clients can still use product after 2 years by keeping an eye on wear & tear and getting replacement of damaged parts.

We mentioned device expected lifetime 10+ years in our device device specifications.

What do you suggest  me, should we keep that model in listing as device expected lifetime 10+ years and I believe, few ender users are still using that devices.

I know, we can put expiry date in GUDID database but not in the FDA listing.

As per my understanding, we need to remove that models from FDA device listings and put expiry date in front  of that model in GUDID instead of deleting from GUDID. 

Would appreciate your feedback,

Thanks