X-Ray 기기의 설계변경에 따른 FDA 510(k) 인허가 영향 평가 모델 개발

김철신; 이세희; 양정삼

doi:10.7315/CDE.2018.361

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저널정보

(사)한국CDE학회
한국CDE학회 논문집 학술저널
한국CDE학회 논문집 제23권 제4호
2018.12 361 - 372 (12page)
DOI : 10.7315/CDE.2018.361

저자정보

김철신 (삼성전자)
이세희 (한국생산기술연구원)
양정삼 (아주대학교)

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초록·키워드

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In the event of design changes in a medical device, the same pathway for approval as the initial released product must be obtained from the authority in accordance with country-specific regulations. In this paper, we collect materials on the change management of medical devices approved by the US Food and Drug Administration (FDA) and analyze the design change data sets from the viewpoint of a digital X-ray device. Based on this analysis, we investigate the association among the items that need a 510(k) to be cleared, and then present a model for assessing the impact of 510(k) clearance on the basis of the related items. From this model, two key contributing causes for decision of change permission are derived, expressing as membership function graphs. Moreover, we will develop a fuzzy-based expert system that predicts the degree of the change registration of an X-ray device through a deductive reasoning in advance for many design change ideas. Finally, we analyze the correlation between the evaluation result of non-experts using this system and the evaluation result depending on the experience of human experts according to FDA 510(k) guidance.

#Design change #FDA regulation #Fuzzy expert system #Membership function #Registration-impact assessment