Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I work for a manufacturer that makes class I adaptive rehab equipment.

I am trying to understand what a device manufacturer's responsibilities (regulatory and otherwise) are to a device after its "service life" or "expected life" is over. Document retention periods are based on the expected life of the device, but does an expected life have meaning if a manufacturer continues to offer replacement parts for an item that has exceeded its expected life? Does a manufacturer have to do anything to end its responsibility for a device after its expected life is over?

Thank you

The manufacturer must define the life of the device, usable life of device, market life of device, support/service life of device, etc.  At some point the company would no longer have to support the device, but to some regulators the manufacturer would always be responsible.  I am not a lawyer, so not sure of the legal bounds that if you establish a market life and support/service life what the true or legal obligations would be for the manufacturer.  However, you are correct there is some obligation the manufacturer would have for servicing even after you stopped selling the product.  As an example for a rehab piece of equipment (making some numbers up just as example):

- Life of device - the established time the manufacturer has set based on testing, MTBF, etc. = 15 years
- Usable life - the amount of time that the product could really be used, usually based on MTBF = 25 years
- Market life - a point in time when the manufacturer determines to no longer sell the product = a date in time, i.e. 31 Dec 2019
- Service/support life - length of time when manufacturer services devices still in the field  = Market life + period of time, i.e. 31 Dec 2019 + 5 years = 31 Dec 2024

As the manufacturer you should established all of these dates in your technical information and then later when deciding no longer to sell a product or a model of a product.  From the example above, say a customer calls up on 7 June 2026 saying my rehab equipment is no longer working, customer service would have a script that says, "We longer support that model 100, but we can offer to upgrade you to model 200 ..."  The most important aspect is documenting all of these times and the rationale behind the time.  In the example, if the life of the device is 15 years, then maybe more realistically the service/support life would be Market life + 15 years.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Oct-2018 16:14
From: Anonymous Member
Subject: Service Life

This message was posted by a user wishing to remain anonymous

I work for a manufacturer that makes class I adaptive rehab equipment.

I am trying to understand what a device manufacturer's responsibilities (regulatory and otherwise) are to a device after its "service life" or "expected life" is over. Document retention periods are based on the expected life of the device, but does an expected life have meaning if a manufacturer continues to offer replacement parts for an item that has exceeded its expected life? Does a manufacturer have to do anything to end its responsibility for a device after its expected life is over?

Thank you

This answer could be different in EU, so I'm answering with respect to US.   To my knowledge, there are no FDA rules mandating service life or useful life.   A company could launch a product and then declare it "end of life" in the same year (subject to commercial consequences).

I've never addressed this question for class I devices, but for the other classes, the challenge is this:  recall obligations are perpetual.    As Richard noted, the typical way to address this is to remove the older product from use, such as by upgrading it to something newer.    The other way is to sell the business unit and all FDA files that go with the product.

Of course, if you declared a device "no longer supported" and someone tries to claim you should replace it due to a design issue 10 years after the end-of-service-life date, then you might have an argument to not support that.    But if the company still has revenue from parts or service, it will definitely be considered fair game to expect support that is no different than your latest product.

If the devices are low cost (i.e., paid in full and expensed rather than financed), you should have good flexibility to announce an end of sales, end of service, and then stop supporting it, but I wouldn't suggest destroying files.




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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
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Original Message:
Sent: 29-Oct-2018 16:14
From: Anonymous Member
Subject: Service Life

This message was posted by a user wishing to remain anonymous

I work for a manufacturer that makes class I adaptive rehab equipment.

I am trying to understand what a device manufacturer's responsibilities (regulatory and otherwise) are to a device after its "service life" or "expected life" is over. Document retention periods are based on the expected life of the device, but does an expected life have meaning if a manufacturer continues to offer replacement parts for an item that has exceeded its expected life? Does a manufacturer have to do anything to end its responsibility for a device after its expected life is over?

Thank you

This message was posted by a user wishing to remain anonymous

Thank you

These answers are very helpful.
Original Message:
Sent: 30-Oct-2018 10:15
From: Roger Cepeda
Subject: Service Life

This answer could be different in EU, so I'm answering with respect to US.   To my knowledge, there are no FDA rules mandating service life or useful life.   A company could launch a product and then declare it "end of life" in the same year (subject to commercial consequences).

I've never addressed this question for class I devices, but for the other classes, the challenge is this:  recall obligations are perpetual.    As Richard noted, the typical way to address this is to remove the older product from use, such as by upgrading it to something newer.    The other way is to sell the business unit and all FDA files that go with the product.

Of course, if you declared a device "no longer supported" and someone tries to claim you should replace it due to a design issue 10 years after the end-of-service-life date, then you might have an argument to not support that.    But if the company still has revenue from parts or service, it will definitely be considered fair game to expect support that is no different than your latest product.

If the devices are low cost (i.e., paid in full and expensed rather than financed), you should have good flexibility to announce an end of sales, end of service, and then stop supporting it, but I wouldn't suggest destroying files.




------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361

Original Message:
Sent: 29-Oct-2018 16:14
From: Anonymous Member
Subject: Service Life

This message was posted by a user wishing to remain anonymous

I work for a manufacturer that makes class I adaptive rehab equipment.

I am trying to understand what a device manufacturer's responsibilities (regulatory and otherwise) are to a device after its "service life" or "expected life" is over. Document retention periods are based on the expected life of the device, but does an expected life have meaning if a manufacturer continues to offer replacement parts for an item that has exceeded its expected life? Does a manufacturer have to do anything to end its responsibility for a device after its expected life is over?

Thank you