FDA issues a new version of ISO 10993-1 guidance, which impact devices with intact skin contact

In September 2023, FDA released a new version of their guidance “Use of International Standard ISO 10993-1”.

In this version FDA guidance document , it is stated that:

  • FDA agrees with the ISO 10993-1:2018 revision regarding focus on minimizing the “number and exposure of test animals by giving preference to in vitro models and to chemical, physical, morphological, and topographical characterization testing, in situations where these methods yield equally relevant information to that obtained from in vivo models.”

The updated version also contains a policy for a least burdensome approach for devices that have intact skin contacting materials that are made from specific synthetic polymers and natural fabrics. FDA recommends that for these devices, specific material information is included in the premarket submission (PMAs, HDE applications, IDE applications, 510(k)s and De Novo requests) in lieu of biocompatibility testing. The approach also relies on certain parts of the QSR and post market controls to identify potential biocompatibility-related issues.

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