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.
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Following the US Medicare agency’s recent proposed rule to give immediate national coverage for breakthrough devices, Simos Kedikoglou spoke with Medtech Insight about what it could mean for companies like his.
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Battelle Memorial Institute, an N95 respirator decontamination system maker, has been back-and-forth with regulators about its Medical Device Reporting protocols, which the US FDA says is lacking. Battelle was granted an emergency use authorization by the agency for its CCDS Critical Care Decontamination System to decontaminate N95 respirators back in March.