Biocompatibility of Implantable Component - What testing, if any?

If we had lots of money or diverted the cost to the customer, we could do lots of testing for biocompatibility. However, we would like to provide customers with implantable component parts that don't cost "an arm and a leg" (this is figuratively speaking of course) or utilize any more test animals than are absolutely necessary.

We currently do USP Class VI plastics testing and no ISO 10993. As a contract manufacturer of non-sterile implantable material, what biocompatibility testing responsibilities do we need to assume? Are these testing requirements primarily meant for finished devices or component manufacturers too? From a risk perspective, we want to market our material for use in implantable devices? Are non-sterile absorbable implantable materials (contacting tissue/bone and blood for > 30 days) viewed any different from a testing perspective?

Lots of questions for a Monday morning. Fiscal responsibilities vs risk assumption is the hot topic for me today. How do the experts confront these issues?

Re: Biocompatibility of implantable component- What testing, if any?

Are these testing requirements primarily meant for finished devices or component manufacturers too?

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Generally, medical device regulatory requirements are always for the medical device, as you have to fulfill them to demonstrate that the medical device is safe and effective. Who makes the test, for which component, etc, is not a concern to the regulations. So, the need for you as a contract manufacturer to make the tests dependson the kind of component and market you´re trying to reach (some companies prefer to buy tested components, which are generally more expensive, than to test them afterwards) and also on you costumer needs.

Note that this theory is true to components in general, and even to other contracted services.

Re: Biocompatibility of implantable component- What testing, if any?

As a contract manufacturer of non-sterile implantable material, what biocompatibility testing responsibilities do we need to assume?

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You (probably) have no regulatory responsibilities for biocompatibility. Those all belong to your customer(s), who cannot legally transfer them to you.

"Probably" is because, in certain circumstances where your knowledge of materials and processes is acknowledged to be expert, and/or in circumstances where you also have medical-device products of your own using similar materials or processes, the FDA is likely to assign co-responsibility to you for your customers' related compliance issues.

Your contractural responsibilities are whatever you agree to with your customer(s). For instance, they and you might agree that you will provably use only materials that have been certified and incoming-inspection-verified to conform to appropriate ISO 10993 qualifications, and that you have appropriately batch-controlled.

Are these testing requirements primarily meant for finished devices or component manufacturers too?

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The relevant distinction is: marketer of a finished device, vs. anyone else involved in the manufacturing process. The former has full regulatory responsibility. The latter has (probably) no regulatory responsibility.

We currently do USP Class VI plastics testing and no ISO 10993.

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USP Class VI material qualification is only FDA-relevant to pharma packaging and dispensing. It has zero relevance to medical devices. Since 1996, ISO 10993 has been mandatory, and the sole acceptable basis, for qualification of medical device materials.

From a risk perspective, we want to market our material for use in implantable devices?

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I'm not sure what the question is here, but risk management is the responsibility of the device marketer.

Are non-sterile absorbable implantable materials (contacting tissue/bone and blood for > 30 days) viewed any different from a testing perspective?

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See FDA Guidance G95-1 for full information on qualification requirements for different use classes.

Re: Biocompatibility of implantable component- What testing, if any?

Your response confirms my thought process too . We will continue doing some level of biocompatibility testing on our material as a "value-added" service to our customers (pre-tested components). Since our implantable material is obviously not being used as packaging material is seems to me we need to reconsider the reasoning for our testing choice. They tell me the customers only ask for USP Class VI testing results (maybe because we sell it like that), why would customers want USP rather than ISO 10993 (just thinking/typing out loud)?. Customer contracts rule here....I will question our sales/customer contacts further.

Why?, Why?, Why?...do we do the things we do. Since I am new at this company I have been asking many questions, maybe that's one of the benefits of not always promoting from within.....sorry pet peave

Re: Biocompatibility of implantable component- What testing, if any?

WisdomseekerSC said:

They tell me the customers only ask for USP Class VI testing results (maybe because we sell it like that), why would customers want USP rather than ISO 10993 (just thinking/typing out loud)?.

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USP still is asked for because it was the rule until 1987. Customers don't always know everything they should, and sometimes have rather low rates of awareness of regulatory and technical changes. Sometimes they have to be educated.

Generally contract manufacturers aren't regulatorily responsible for their customers' regulatory shortcomings, but that stance might be hard to defend if you're making implant parts and the customers aren't asking about ISO 10993. The FDA likely would expect someone at your company to be aware enough of the fundamental rules to have discussed the issue with the customer(s) during contract development and/or contract review.

Re: Biocompatibility of implantable component- What testing, if any?

Hi

I think part of the reason customers ask from USP Class IV testing from a contractor, is that the customer knows that ultimately they will have to do ISO10993 testing themselves, and that any modifications they make to the original component will invalidate much of the subcotractors work, so there is little point in asking for full ISO testing.

However the customer may still ask the sub-contractor for USP testing in order to screen materials for compatibility, on the basis that if it passes USP, there is a high liklihood that it will pass ISO10993.

Chris