\uc758\ub8cc\uae30\uae30\ub294 \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc5d0 \uc758\ud574 \uaddc\uc81c\ub429\ub2c8\ub2e4. \ud2b9\uc815 \uc758\ub8cc \uae30\uae30\ub294 FDA \uc2b9\uc778\uc744 \ubc1b\uc544\uc57c \ud310\ub9e4\ub429\ub2c8\ub2e4. \ucf54\uc2a4\ubbf8\ub808\uadf8\ub294 \uc758\ub8cc\uae30\uae30 \ubbf8\uad6d \uc218\ucd9c, FDA \uc758\ub8cc\uae30\uae30 \ub4f1\ub85d\/\uc2b9\uc778, FDA 510(k), \uc2dc\ud310\uc804 \ud5c8\uac00 (PMA), FDA HDE, FDA IDE, FDA \ub4dc \ub178\ubcf4 \uc11c\ube44\uc2a4\ub97c \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\ubaa8\ub4e0 \uc758\ub8cc\uae30\uae30 \uc5c5\uccb4\ub294 FDA\uc5d0 \uc758\ub8cc\uae30\uae30 \ub4f1\ub85d\uc744 \ud574\uc57c \ud569\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30 \uc5c5\uccb4\ub294 FDA\uc640 \uc911\uac1c\uc790 \uc5ed\ud560\uc744 \ud560 \uc218 \uc788\ub294 \ubbf8\uad6d \ub300\ub9ac\uc778\uc744 \uc9c0\uc815\ud574\uc57c \ud569\ub2c8\ub2e4. \ucf54\uc2a4\ubbf8\ub808\uadf8\ub294 \uc758\ub8cc\uae30\uae30 FDA \ub4f1\ub85d\uc744 \uc704\ud55c \uc9c0\uc6d0\uc744 \ud569\ub2c8\ub2e4.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
FDA 510(k)\ub294 \uc2dc\ud310 \uc804 \uc2e0\uace0\ub85c \ud574\ub2f9\uae30\uae30\uac00 \ubc95\uc801\uc73c\ub85c \uc774\ubbf8 \uc2dc\ud310\ub418\uace0 \uc788\ub294 \uae30\uae30\uc640 \ub3d9\uc9c8\uc131\uc744 \uac00\uc84c\ub2e4\ub294 \uac83\uc744 \uc99d\uba85\ud558\ub294 \uacfc\uc815\uc73c\ub85c \ucf54\uc2a4\ubbf8\ub808\uadf8\ub294 FDA 510(k) \uc778\uc99d\uc744 \ub3c4\uc640\ub4dc\ub9bd\ub2c8\ub2e4.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\uace0\uc704\ud5d8 \uc7a5\uce58(\ud074\ub798\uc2a4 III)\uc758 \uacbd\uc6b0 \uc2dc\ud310\uc804 \ud5c8\uac00(PMA)\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30\uc758 \uc548\uc815\uc131\uacfc \ud6a8\uc728\uc131\uc744 \uacfc\ud559\uc801 \uadfc\uac70\ub97c \ud1b5\ud574 \uc2b9\uc778 \ubc1b\ub294 \uc808\ucc28\ub85c \uc11c\ub958 \uc2ec\uc0ac\uc640 \uc81c\uc870\uc2dc\uc124 \uc2ec\uc0ac, \uc784\uc0c1\uc2dc\ud5d8 \uc2e4\uc2dc\uc5d0 \ub300\ud55c \uc801\ud569\uc131 \ub4f1 \uc138\ubc00\ud55c \ud655\uc778 \uc808\ucc28\uac00 \uc9c4\ud589\ub418\uba70, \uaddc\uc815\uc5d0 \ub530\ub978 \uc784\uc0c1\uc5f0\uad6c\uc640 \ud6a8\ub2a5\uc5d0 \ub300\ud574 \uc644\ubcbd\ud55c \ubcf4\uace0\uc790\ub8cc\ub97c \uc791\uc131\ud574\uc57c \ud569\ub2c8\ub2e4. \uc2dc\ud310\uc804 \ud5c8\uac00(PMA)\uc740 \ucf54\uc2a4\ubbf8\ub808\uadf8\uc640 \uc0c1\ub2f4\ud558\uc138\uc694.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\ud76c\uadc0 \uc9c8\ud658\uc744 \uac00\uc9c4 \ud658\uc790\uc758 \uce58\ub8cc \ub610\ub294 \uad00\ub9ac\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc758\ub8cc\uae30\uae30\uc758 \uacbd\uc6b0 \uc2dc\ud310\uc804 \ud5c8\uac00(PMA)\uc774 \uc5b4\ub824\uc6b8 \uc218 \uc788\ub294\ub370 \uc774 \ub54c FDA HDE (\uc778\ub3c4\uc801 \uae30\uae30 \uba74\uc81c)\ub97c \ud1b5\ud574 \uace0\uc704\ud5d8 3\ub4f1\uae09 \uc758\ub8cc\uae30\uae30\ub97c \uc2b9\uc778\ubc1b\uac8c \ub429\ub2c8\ub2e4. \ucf54\uc2a4\ubbf8\ub808\uc2a4\uc5d0\uc11c FDA HDE \uad00\ub828 \ucee8\uc124\ud305\uc744 \ubc1b\uc544\ubcf4\uc138\uc694<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\uc2dc\ud310\uc804 \ud5c8\uac00(PMA)\ub97c \ucda9\uc871\ud558\ub824\uba74 \uc758\ub8cc\uae30\uae30 \uc784\uc0c1\uc2dc\ud5d8\uc744 \uc218\ud589\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \ub54c FDA IDE (\uc758\ub8cc\uae30\uae30 \uc784\uc0c1\uc2dc\ud5d8 \uc2b9\uc778 \uba74\uc81c)\ub97c \ud1b5\ud574 \uc758\ub8cc\uae30\uae30 \uc0ac\uc6a9\uacfc \ud310\ub9e4\uc5d0 \ud2b9\ubcc4 \uad8c\ud55c\uc744 \uac00\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. FDA IDE \uc2e0\uccad\uc740 \ucf54\uc2a4\ubbf8\ub808\uadf8\uc640 \uc0c1\uc758\ud558\uc138\uc694.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\uc758\ub8cc\uae30\uae30\uc5d0 \uc911\ub300\ud55c \uc704\ud5d8\uc740 \uc5c6\uc73c\ub098 \ube44\uad50\ud560 \ub9cc\ud55c \ub3d9\ub4f1\uc758\ub8cc\uae30\uae30\uac00 \uc5c6\ub294 \uacbd\uc6b0 3\ub4f1\uae09\uc73c\ub85c \ubd84\ub958\ub429\ub2c8\ub2e4. \uc774 \ub54c FDA \ub4dc \ub178\ubcf4 \uc2e0\uccad(513[g])\uc744 \ud1b5\ud574 \uc758\ub8cc\uae30\uae30\ub97c \ud3c9\uac00\ud558\uac8c \ub429\ub2c8\ub2e4. FDA \ub4dc \ub178\ubcf4 \uc2e0\uccad, \ucf54\uc2a4\ubbf8\ub808\uadf8\uc640 \uc0c1\uc758\ud558\uc138\uc694.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\ubb34\ub8cc \uc0c1\ub2f4\uc744 \uc6d0\ud558\uc2dc\uba74 \uc9c0\uae08 \uc5f0\ub77d\ud558\uc2ed\uc2dc\uc624.<\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t