Abstract:This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them. Based on the experience of approval of the first domestic custom‐designed bone implant, we consider the process of gaining conditional approval for urgently‐needed medical devices and medical devices for rare diseases, as well as the guidance available for clinical investigation. We also streamlined the scientifically adm… Show more
“…These must also be limited in number and subject to significant medical board scrutiny. Medical authorities are currently at a significant cross-road as to how to provide custom implants for more widespread use [73].…”
Section: Am Quality Inspection and Certificationmentioning
“…These must also be limited in number and subject to significant medical board scrutiny. Medical authorities are currently at a significant cross-road as to how to provide custom implants for more widespread use [73].…”
Section: Am Quality Inspection and Certificationmentioning
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