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Biocompatibility Risk Analysis for Clinical Practitioner

W

WaterNext

#1
Hi,

I am working on the biocompatibility portion of a 510(k) submission and I have a question about risk analysis precluding biocompatibility analysis when the contact is the Clinical Practitioner.

My questions come from the interpretation of the FDA Guidance on 10993.

My device does not touch a patient. It is used solely on resected tissue. But per the FDA guidance I see that references to "body" contact can be interpreted as Clinical Practitioner (foot notes on page 1). The contact with my device is transient (very brief/transient contact with body tissue) by the clinical practitioner, which again is referenced in a foot note (page 2): "for devices with transient contact, assessment of biocompatibility risk should be conducted to determine if testing is needed."

The question is, does anyone have experience with what kinds of rationale for presenting that no biocompatibility testing is needed from a Clinical Practitioner risk perspective? Can I simply say the presence of RoHS and REACH certification of the contacting materials make the chance of biocompatibility issues arising from transient touch negligible?

Thanks,
WaterNext
 
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D

deniseritta

#2
Hello, I'm from Brazil and my company has many questions about the biocompatility tests to attend a new legislation in our country ( emergogroup.com/sites/default/files/brazil-anvisa-rdc-40-2015-cadastro-en.pdf[/url

Our health care products have human body contact, but my doubt is in what part of the product shall be performed the biocompatibility tests? In the final product? In the components? In the raw material? In the product after sterilization?

We have infusion sets, nonwoven gowns and drapes and dialysis sets to test.

Can anyone help us?
 

Marcelo

Inactive Registered Visitor
#3
Hi,
Can I simply say the presence of RoHS and REACH certification of the contacting materials make the chance of biocompatibility issues arising from transient touch negligible?
No, you need to perform the biological evaluation (including the risk assessment and) verify of there existis enough data to conclude that the risks are acceptable, without the need for testing.

The question is, does anyone have experience with what kinds of rationale for presenting that no biocompatibility testing is needed from a Clinical Practitioner risk perspective?
Yes, but again, this depends on the data and strength of the data (and also depends on the fact that the existing data is really applicable to the device is question, because most of the time data exists for a specific material or device, but the device in question includes changes in the manufacturing process that introduces, for example, residues or changes in the material properties that in the end invalidate current data - this is why material characterization is so important).
 

Marcelo

Inactive Registered Visitor
#4
Hello, I'm from Brazil and my company has many questions about the biocompatility tests to attend a new legislation in our country ( emergogroup.com/sites/default/files/brazil-anvisa-rdc-40-2015-cadastro-en.pdf[/url

Our health care products have human body contact, but my doubt is in what part of the product shall be performed the biocompatibility tests? In the final product? In the components? In the raw material? In the product after sterilization?

We have infusion sets, nonwoven gowns and drapes and dialysis sets to test.

Can anyone help us?
Biological evaluation (and the related risk management) is performed for the whole, final product.
 
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