FDA Biocompatibility Requirements - Transitory Contact

L

lin2020

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Hi,

My company is developing a sensor patch made of biocompatible foam that looks similar to the EKG electrode except that ours is a bit thicker (approximately 0.6 cm), so supposedly when it is attached to the patient's body, the upside will not touch the patient.
We already sent the previous version of the sensor to a third-party laboratory for ISO 10993 testing (<12 hours, intact-skin contact category) and the results indicated no biocompatibility concerns.

Recently, because of clinical feedback, we are looking to print on the upside of the sensor to help the users distinguish the two sides, and to prevent the print from coming off during use, we will add a transparent layer on top.
However, the available biocompatible adhesive is not strong enough to hold the transparent layer in place for multiple uses because the print will affect its adhesiveness. We turn to the adhesive that has not been subject to biocompatibility testing,

My questions are:
1. We think that the non-biocompatible adhesive will be on the upside and is very unlikely to touch the patients under usual use scenario. We think based on ISO 10993-1, the adhesive is categorized as "transitory contact, " and would therefore not requiring biocompatibility testing.
Is this explanation usually acceptable to the FDA? Can different parts of a single device have different contact categories?

Annotation 2020-07-01 111720.png

2. Based on the FDA guidance (Use of International Standard ISO 10993-1), it seems that they are particularly concerned about materials interacting with each other, especially polymers. Would this raise the concerns of the foam polymer interacting with or leached by the adhesive, therefore making the previous explanation not acceptable?
 
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planB

planB

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#2
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lin2020

ad Q1:
you may want to take a decision for the adhesive, based on your product design: either it is not in potential patient contact when your device is applied according to its intended use - then ISO 10993-1 does not apply; or the adhesive is in potential body contact when the device is used as intended.

For the latter case, your final device has to be biocompatible. The exposure duration "transitory" still requires you to perform a risk-based biocompatibility evaluation for the device also considering the adhesive. You may waive dedicated biocompatibility testing (and only rely on existing data) to support this evaluation - with a caveat, quote from ISO 10993-1:2018, section 5.3.2:

However, for products made with materials such as coatings or lubricants that could be left in contact with body tissues after the medical device is removed, it is possible that a more detailed biocompatibility assessment will be necessary. Cumulative use should also be considered.
Click to expand...
So if you claim potential body fo the adhesive, FDA might challenge you in case your biocompatibility evaluation does not consider the adhesive as part of your final device.

> Can different parts of a single device have different contact categories?

Yes, they can - quote from ISO 10993-1:2018, section 5.1:

Certain medical devices might fall into more than one body contact or duration category, in which case evaluation appropriate to each category shall be carried out.
Click to expand...
ad Q2:
You may want to gather adequate physical and chemical composition information to reach an informed decision for your desired combination of materials (over their lifecycle). If existing data does not allow you to perform this assessment, then further experimental characterization (e.g. chemical analysis of extracts and even biological testing in a second step) may be necessary.

HTH,
 
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