|
KMID : 1142220130080010111
|
|
Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.111 ~ p.116
|
|
|
A Study on Clinical Performance Assessment of in Vitro Diagnostic Medical Devices (IVDD)
|
|
Ihm Chun-Hwa
Yoo Soo-Jin
Sohn Yong-Hak
Ji Mi-Suk
Lee Sang-Kwang
Choi Eun-Hye
Chang Yoon-Hwan
Jeon Byung-Ryul
Roh Kyoung-Ho
Sohn Mi-Jin
|
|
|
Abstract
|
|
|
|
The performance of an in vitro diagnostic medical devices (IVDD) consists of analytical and, where applicable, the clinical performance and method comparison. The technical documentation is prepared for premarket review and approval regarding the above characteristics in order to meet regulatory requirements. Clinical performance of an IVDD includes clinical sensitivity and specificity using human-derived material. Our aim was to study domestic and foreign laws, regulations and guidelines as a basis for guideline development of clinical performance approval guidelines of the IVDD that fit in the Korean situation. We primarily analyzed final documentation of the Global Harmonization Task Force (GHTF) and the related regulations of USA, Europe, Japan, Canada, Australia and Korea. The issues of scientific validity and ethical considerations were included in this study. This study could be used for basic data to set up an appropriate system for approval and evaluation of the IVDD and will also contribute to the industrial expansion and public health promotion.
|
|
|
KEYWORD
|
|
|
In vitro diagnosis, performance evaluation, approval and evaluation
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|