| Autor: |
Hung-Chan Kao, Yu-Shu Lai, Cheng-Kung Cheng |
| Jazyk: |
angličtina |
| Rok vydání: |
2016 |
| Předmět: |
|
| Zdroj: |
Journal of Orthopaedic Translation, Vol 7, Iss C, Pp 30-37 (2016) |
| Druh dokumentu: |
article |
| ISSN: |
2214-031X |
| DOI: |
10.1016/j.jot.2016.06.027 |
| Popis: |
Background/objective: When researchers or developers wish to apply their findings to clinical usages, it must be approved by public authorities such as the US Food and Drug Administration (FDA). In addition to the development records and risk control documents, all of the materials and testing must be completed by laboratories or manufacturers with good quality controls in accordance with related regulations or standards. The Orthopaedic Device Research Center dynamic hip screw system (ODRC-DHS system), which was developed by the ODRC, National Yang-Ming University, Taipei, Taiwan, obtained FDA 510(k) clearance in 2011. Methods: The application process was divided into five steps: (1) make sure that the product is a medical device and classify it; (2) find the predicate devices cleared by the FDA; (3) research any standards and/or guidance documents; (4) prepare the appropriate information for premarket submission to the FDA; and (5) send premarket submission to the FDA and interact with the FDA staff. Results and Conclusion: The relevant regulations, guidelines, and strategies were detailed by step-by-step demonstration so that readers can quickly understand the requirements and know-how of a translational research. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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