Translational Research Of One Dynamic Hip Screw System—from The SCI To The FDA
Authors: Hung-Chan Kao, Yu-Shu Lai, Cheng-Kung Cheng
Summary:
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.
Keywords
FDA 510(k); medical device; SCI; translate
Citation: Hung-Chan Kao, Yu-Shu Lai, Cheng-Kung Cheng Translational Research Of One Dynamic Hip Screw System—from The SCI To The FDA doi:10.1016/j.jot.2016.06.027
Received: 29 April 2016, Revised: 10 June 2016, Accepted: 17 June 2016, Available: online 19 July 2016
Copyright: © 2016 The Authors. Published by Elsevier (Singapore) Pte Ltd on behalf of Chinese Speaking Orthopaedic Society. This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).
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.
Conflicts of interest
The authors have no conflicts of interest to declare.
Funding/support
No financial or grant support was received for the work described in this article.
