규제 제출
FDA ?뱀씤, 媛??鍮좊Ⅴ怨??뺤떎?섍쾶. (FDA Clearance: Fast, Certain, Complete.)
?⑥닚 510(k)遺???쒖씠???믪? De Novo, Pre-Sub源뚯?. ?곌컙 50嫄??댁긽???깃났 ?щ?瑜?蹂댁쑀???꾨Ц媛?ㅼ씠 **eSTAR** ?쒖텧??紐⑤뱺 怨쇱젙??二쇰룄?⑸땲??
The Challenge
Predicate Strategy
?뱀씤 ?깃났??90%瑜?醫뚯슦?섎뒗 '湲고뿀媛 ?쒗뭹(Predicate Device)' ?좎젙???꾨왂?곸쑝濡??섑뻾?섏뿬 ?낆쬆 遺?댁쓣 理쒖냼?뷀빀?덈떎.
Pre-Sub Meeting
FDA ?ъ궗愿怨??ъ쟾 誘명똿(Q-Sub)??二쇰룄?섏뿬, ?꾩긽 ?쒗뿕 ?꾨줈?좎퐳??????숈쓽瑜?誘몃━ 諛쏆븘?닿퀬 遺덊솗?ㅼ꽦???쒓굅?⑸땲??
RTA Zero
eSTAR ?묒꽦??湲곗닠???ㅻ쪟濡??명븳 '?묒닔 嫄곕?(Refuse to Accept)'瑜??먯쿇 李⑤떒?섎뒗 寃利??꾨줈?몄뒪瑜??댁쁺?⑸땲??
자주 묻는 질문
De Novo???몄젣 ?꾩슂?쒓???
湲고뿀媛???좎궗 ?쒗뭹(Predicate)???꾪? ?놁쓣 ???꾩슂???덉감濡? ????꾨Ц???Class II ?깃툒???뺣낫???쒕┰?덈떎.
?꾩긽?쒗뿕???꾩닔?멸???
510(k)??90%???꾩긽 ?놁씠 ?깅뒫 ?쒗뿕(Bench Test)留뚯쑝濡??뱀씤 媛?ν빀?덈떎.
?ㅻぐ 鍮꾩쫰?덉뒪 媛먮㈃ ?쒗깮? ?대뼸寃?諛쏅굹??
FDA 留ㅼ텧 ?좉퀬 ?덉감瑜???됲븯???ъ궗 ?섏닔猷뚮? 理쒕? 75%源뚯? 媛먮㈃諛쏅룄濡??꾩??쒕┰?덈떎.