Discussion of Enlightenment from the Reorganization of CDRH Regulatory for Medical Device / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 154-157, 2020.
Article
in Chinese
| WPRIM
| ID: wpr-942718
ABSTRACT
This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
United States
/
United States Food and Drug Administration
/
Device Approval
/
Marketing
Country/Region as subject:
North America
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2020
Type:
Article
Similar
MEDLINE
...
LILACS
LIS