Pre-clinical Animal Studies for long term implantable medical devices

A

Aliasanonymous

#1
Hi covers,

I have been told that animal testings are only required for long term implantable medical devices. Is that true? How could it be that a clinical investigation (clinical trial) is required but not a pre-clinical animal study? I am looking at a class III device.

Is there a guideline for decisions on whether or not a pre-clinical animal study is required?

Thank you in advance!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Pre-clinical Animal Studies

Hi covers,

I have been told that animal testings are only required for long term implantable medical devices. Is that true? How could it be that a clinical investigation (clinical trial) is required but not a pre-clinical animal study? I am looking at a class III device.

Is there a guideline for decisions on whether or not a pre-clinical animal study is required?

Thank you in advance!
Hi,

Animal studies are typically required wherever the initial risk in human-subject trial is considered too high.

Cheers,
Ronen.

PS It could help if you specified what regulatory system you are referring to (FDA, EC etc.), and what sort of device is at stake. Thanks.
 
Last edited:

Sam Lazzara

Trusted Information Resource
#3
Re: Pre-clinical Animal Studies

The attached 2010 US FDA guideline does not exactly answer your question but it should be useful just the same. It is called General Considerations for Animal Studies for Cardiovascular Devices.

Some of FDA's guidelines for premarket submissions provide specific animal study guidance for particular devices.

Overview - 2010 Guidance mentioned above

FDA recommends that you consider the following general principles when developing animal study strategies for cardiovascular devices:

  • You should follow Good Laboratory Practices (GLP) for all animal studies involving cardiovascular devices that are to be submitted to the Agency.
  • The animal model selected for a cardiovascular study should be generally accepted for the study of the device type. That is, there should be a reasonable amount of scientific evidence that the animal model has utility for the study of the product class.
  • FDA’s primary purpose in asking for an animal study for a particular device is to demonstrate sufficient safety including performance and handling. A secondary objective is to study the efficacy of the device, if applicable. Sometimes the performance of a particular device is intricately linked to its safety, such as for products that provide circulatory support.
  • The in vivo setting generally provides FDA with an initial assessment of how the device interacts with biologic systems and also how the biologic system may affect the device, such as via device corrosion and structural deformities.
  • You should observe the best practices of refinement, reduction, replacement, and current standards of humane veterinary care and use. This may also involve consideration of available validated alternatives.
 

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A

Aliasanonymous

#4
Re: Pre-clinical Animal Studies

Thank you for the replies.

Ronen,
Does that mean it is all risk based? So if the device is not a new device and does not have novel features, I can go straight to human-clinical tests and skip the animal tests (given that tests have been done on similar existing devices)?
We are looking at both the FDA and EC requirements on class III transient invasive devices.


Sam,
Thank you for the document. It will come in handy when we start structuring the tests. The problem now is whether or not we need to do them. :confused:
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Pre-clinical Animal Studies

Thank you for the replies.

Ronen,
Does that mean it is all risk based? So if the device is not a new device and does not have novel features, I can go straight to human-clinical tests and skip the animal tests (given that tests have been done on similar existing devices)?
We are looking at both the FDA and EC requirements on class III transient invasive devices.
I'm sorry, but based on general descriptions I can only give general answers. Saying that the device is a "class III transient invasive device" is a step in the right direction but it's not enough for a definite answer. providing the FDA's ProCode would be very helpful. If you are reluctant to expose more in a public space please send me a PM.

Cheers,
Ronen.
 

planB

Super Moderator
#6
Re: Pre-clinical Animal Studies

Thank you for the replies.

Ronen,
Does that mean it is all risk based? So if the device is not a new device and does not have novel features, I can go straight to human-clinical tests and skip the animal tests (given that tests have been done on similar existing devices)?
We are looking at both the FDA and EC requirements on class III transient invasive devices.


Sam,
Thank you for the document. It will come in handy when we start structuring the tests. The problem now is whether or not we need to do them. :confused:
Hi,

have a look at ISO 10993-1, which is harmonized in Europe and a recognised consensus standard in the US. Yes, you have to follow a risk-based approach.

Follow the flow chart in ISO 10993-1 and have a look at the tests-to-consider matrix in the annex of the standard.

In addition have a look at this FDA draft guidance, which highlights the Agency's expectations when interpreting ISO 10993-1:

"Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", April 2013

This draft guidance contains a slightly modified flow chart.

Generally,
1) Only test what you do not know
2) Prefer in-vitro over in-vivo testing if there is an adequate and valid in-vitro test available
3) If you can demonstrate device safety and performance in an appropriate in-vivo study of course you would not skip these animals tests and put humans on risk; at least in Europe you would a hard time with the Ethics Committee justifying a clinical study when the same data could be generated in an animal study or even in an in-vitro test ....

HTH,

Gerhard
 
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