W
WaterNext
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
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