Medical Devices – Latest Updates

US-FDA publishes a revised guidance “Use of International Standard ISO 10993-1”

19 September 2023

On September 8, the FDA published an update of the document “Use of International Standard ISO 10993-1”. This document was adapted to the newest ISO 10993-1:2018.

While not explicitly specified in ISO 10993-1:2018 and ISO 10993-11:2018, the FDA does not consider a 14-day subacute toxicity test sufficient for prolonged term devices with a contact duration of more than 14 and up to 30 days if the systemic toxicity needs to be conducted to evaluate these endpoints. Instead, the FDA recommends, that the choice of the test duration should be based on the duration of device use.

As a major change to the previous version of the FDA guidance, a new Attachment G “Biocompatibility of certain Devices in Contact with Intact Skin” has been added. Following the least burdensome approach, this attachment details conditions, under which biological tests can be waived. The new approach is based on QMS specific measures and can be used for intact skin surface devices independent from the contact duration. The new attachment includes a list of synthetic polymers and natural fabrics, for which the new method can be applied. It also details several exceptions, where the new approach is not applicable.

Based on our experience with the previous version of the FDA guidance document which contained several additional requirements and differences compared to the ISO 10993 standards, we recommend carefully reviewing FDA-specific requirements before planning laboratory tests to avoid deficiencies or unnecessary tests.

For further information, please contact our experts.

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