Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices
نویسندگان
چکیده
منابع مشابه
Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices
OBJECTIVE To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. DESIGN The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to ...
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ژورنال
عنوان ژورنال: The Open Rheumatology Journal
سال: 2008
ISSN: 1874-3129
DOI: 10.2174/1874312900802010007