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?
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?
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?

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?