Testing compliant to USP Class VI and ISO10993-1 compliant. Is that possible?

So here is a new one - a customer has requested us to conduct testing compliant to USP Class VI and ISO10993-1 compliant. Is that possible?

I know that performing a USP Class VI test even for a 30 day period will still not perform to ISO10993-1 per (General Program/Bluebook Memo G95-1)

We are not a medical manufacturer, nor do we have the desire to be one. The insurance costs are astronomical. We provide them with product used in dairy operations but not in vivo.

Any thoughts? I know this testing is outrageously expensive.

What is the material that they are proposing you to test?

Is the customer providing enough revenue to even consider doing the test?

Would the tests open the door for the possibility for a larger customer base?

And for those who wan to read the blue book reference, it is at
http://www.fda.gov/cdrh/g951.html

The material is a propietary silicone based elastomer.

The revenue is decent, not spectacular, that is why I am hesitant to proceed, and as much as it kills me to say this we do not really want to increase that aspect of the business. There are too many variables when you start dealing with medical and in vivo tubing.

To be honest I would not even know where to begin to find a lab that can conduct the testing

Are you sure that the material actually needs extensive testing? This is from the link provided by patahaconsulting earlier:

Some devices are made of materials that have been well characterized
chemically and physically in the published literature and have a long
history of safe use. For the purposes of demonstrating the substantial
equivalence of such devices to other marketed products, it may not be
necessary to conduct all the tests suggested in the FDA matrix of this
guidance. FDA reviewers are advised to use their scientific judgement
in determining which tests are required for the demonstration of
substantial equivalence under section 510(k).

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IEGeek said:

So here is a new one - a customer has requested us to conduct testing compliant to USP Class VI and ISO10993-1 compliant. Is that possible?

I know that performing a USP Class VI test even for a 30 day period will still not perform to ISO10993-1 per (General Program/Bluebook Memo G95-1)

We are not a medical manufacturer, nor do we have the desire to be one. The insurance costs are astronomical. We provide them with product used in dairy operations but not in vivo.

Any thoughts? I know this testing is outrageously expensive.

Click to expand...

Both documents you reference are used to determine the testing required to show biocompatibility. It is dependent on the nature and length of exposure and possible to meet both, as the FDA Blue Book Memo may require less testing in some cases and additional testing in others. I know from experience that a test for limited skin exposure, Class I (cytotoxicity, sensitization and irritation) costs $5k and takes 90 days. Testing costs and time, I'm sure, will go up from there for your Class IV material. For educational purposes, I have attached the tables from 10993-1 for you to compare to the FDA BB Memo. Most manufacturers will not certify their materials because of the factors you mentioned. The device manufacturer should determine and contract out the appropriate testing since it is closer to the application and use.

JSW05 said:

Are you sure that the material actually needs extensive testing? This is from the link provided by patahaconsulting earlier:

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Since the material is propriatary and has not been used in a medical device, that option is out.

Al Rosen said:

Since the material is propriatary and has not been used in a medical device, that option is out.

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The first part is in evidence (that the material is proprietary) but the second isn't (that it has never been used in a medical device). And it's possible, but not likely, that equivalence could be established somewhere in the universe of silicon-based elastomers that have been used in medical devices.

My understanding - and this is where it gets confusing - these hoses are used in a dairy operation for the transport of dairy products in a manufacturing environment. That is why I am unclear as to the necessity of Class VI testing.

As for the use in the medical field, the product is not designed to be in a medical application. They are supposed to be Food Grade Silicone Hoses - nothing more.

The more I research and read your replies, this is a big can of worms that we should not even be involved in. Our drawing specifies that this is "Silicone Elastomer hose for use in a dairy manufacturing operation"

I hope you can all see why I am befuddled. I make truck parts for OEMs, I dont make in vivo hoses.

This is too involved for a sunny Friday afternoon. Maybe I should go home and head out onthe boat.......

JSW05 said:

The first part is in evidence (that the material is proprietary) but the second isn't (that it has never been used in a medical device). And it's possible, but not likely, that equivalence could be established somewhere in the universe of silicon-based elastomers that have been used in medical devices.

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I'm not sure that equivalence is enough in this case, as you have experienced with FDA 510(k)s.

Re: ISO 10993-1:2003
Can I request a full copy of this standard for my reference? Hope that you can provide me.
I really appreciated your kind support.
Thank you.

Best Regards,
Mildred