Implantable devices/implantation therapy biocompatibility

Regulatory guidelines instruct that implant leachates should not produce adverse local, systemic, tumorigenic, reproductive, or developmental effects to be approved. Evaluations of biocompatibility, which are described in these standards, are all part of the overall safety and efficacy assessment of medical devices and advanced therapy medical products, for example, scaffolds for tissue engineering, tissue adhesives, hip replacements, and surgical meshes for tissue support. 

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