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FDA Proposes Negating Need For Biocompatibility Testing For Certain Materials

The agency says sponsors of some medical devices that touch skin may no longer need to provide biocompatibility testing data if the materials they’re made of have a safe history.

A hand touching plastic polymer dye granules.

Sponsors of certain medical devices that touch skin would no longer need to provide biocompatibility testing data if they can show their material has a safe history, according to a draft guidance released by the US Food and Drug Administration.

The agency says its 2016 guidance on biocompatibility that addresses international standard ISO 10993-1 will remain the guiding document for regulators while its proposal is being finalized. However, the...

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