Dirk S
Registered
One of our customers got a pushback by a reviewing authority on the categorization of the contact duration based on ISO 10993-1:2018. According to our client, the device has a cumulative prolonged contact duration and endpoint consideration (incl. chemical characterization) was performed accordingly.
However, the reviewing authority required to classify the device as a permanent contact device, based on ISO TS 21726:2019 Clause 5.2 NOTE 2:
“A medical device that contacts the body once per week for a life-time (i.e. 9,9 years = 1 contact d/week × 52 weeks/year × 70 years) ÷ 365 d/year) would result in the selection of 10 μg/d as the TTC value.”
Based on this, endpoint consideration and chemical characterization testing would need to be redone, said the reviewing authority.
ISO TS 21726 is released since 2019 and this is the first time in the last 4 years, that cumulated contact duration categorization according ISO 10993-2:2018 was not accepted because of this NOTE 2 of ISO TS 21726:2019.
Is there a common understanding, that contact duration of e.g. 5 min per week over a time of 30 years are counted as a whole body contacting day would end up as 1,560 device contact days and permanent contact duration and not (as according to ISO 10993-1:2018) as 5.42 days and prolonged contact duration?
I would appreciated your thought on this matter, as this argumentation of the reviewing authority has a huge impact on device classification and biological endpoint consideration. It would mean, that ISO 10993-1:2018 and contact duration calculation according Clause 5.3 would be overruled by ISO TS 21726.
However, the reviewing authority required to classify the device as a permanent contact device, based on ISO TS 21726:2019 Clause 5.2 NOTE 2:
“A medical device that contacts the body once per week for a life-time (i.e. 9,9 years = 1 contact d/week × 52 weeks/year × 70 years) ÷ 365 d/year) would result in the selection of 10 μg/d as the TTC value.”
Based on this, endpoint consideration and chemical characterization testing would need to be redone, said the reviewing authority.
ISO TS 21726 is released since 2019 and this is the first time in the last 4 years, that cumulated contact duration categorization according ISO 10993-2:2018 was not accepted because of this NOTE 2 of ISO TS 21726:2019.
Is there a common understanding, that contact duration of e.g. 5 min per week over a time of 30 years are counted as a whole body contacting day would end up as 1,560 device contact days and permanent contact duration and not (as according to ISO 10993-1:2018) as 5.42 days and prolonged contact duration?
I would appreciated your thought on this matter, as this argumentation of the reviewing authority has a huge impact on device classification and biological endpoint consideration. It would mean, that ISO 10993-1:2018 and contact duration calculation according Clause 5.3 would be overruled by ISO TS 21726.