Cargando…
Correlation Between Conditional Approval and Customized Bone Implant Devices
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 proc...
Autores principales: | Guo, Xiao‐lei, Liu, Bin, Lu, Zhong |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons Australia, Ltd
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430462/ https://www.ncbi.nlm.nih.gov/pubmed/30834707 http://dx.doi.org/10.1111/os.12415 |
Ejemplares similares
-
Custom-Made Zirconium Dioxide Implants for Craniofacial Bone Reconstruction
por: Kozakiewicz, Marcin, et al.
Publicado: (2021) -
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices
por: Van Norman, Gail A.
Publicado: (2016) -
Titanium-Based Biomaterials for Preventing Stress Shielding between Implant Devices and Bone
por: Niinomi, M., et al.
Publicado: (2011) -
Bimatoprost Implant: First Approval
por: Shirley, Matt
Publicado: (2020) -
Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022
por: Luo, Xingxian, et al.
Publicado: (2023)