{"id":14190,"date":"2026-10-15T13:50:50","date_gmt":"2026-10-15T04:50:50","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&p=14190"},"modified":"2026-10-15T13:50:50","modified_gmt":"2026-10-15T04:50:50","slug":"fda-medical-device-ifu-webinar-ko","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/fda-medical-device-ifu-webinar-ko\/","title":{"rendered":"\uc758\ub8cc\uae30\uae30 \ubbf8\uad6d FDA \uc9c4\ucd9c \uc6e8\ube44\ub098, IFU\uc640 \ub77c\ubca8\ub9c1 \uc694\uac74\uae4c\uc9c0"},"content":{"rendered":"\n

\ud55c\uc0d8\uae00\ub85c\ubc8c\uc774 \ubbf8\uad6d FDA \uaddc\uc81c \uc804\ubb38 \ub85c\ud38c Amin Wasserman Gurnani(AWG)\uc640 \ud568\uaed8 \uc758\ub8cc\uae30\uae30 \ubbf8\uad6d \ucd9c\uc2dc\ub97c \uc8fc\uc81c\ub85c \ud55c \uc6e8\ube44\ub098 “How to Get It Right: Legally Launching a Medical Device in the U.S.”\ub97c \uacf5\ub3d9 \uac1c\ucd5c\ud569\ub2c8\ub2e4. \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc900\ube44\ud558\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 FDA \uc778\ud5c8\uac00 \uacfc\uc815\uc5d0\uc11c \ud655\uc778\ud574\uc57c \ud560 \uaddc\uc81c \uc694\uac74\uacfc, \uc2b9\uc778 \uac80\ud1a0\uc758 \ud544\uc218 \uc790\ub8cc\uc778 \uc0ac\uc6a9\uc124\uba85\uc11c(IFU)\uc640 \ub77c\ubca8\ub9c1\uc744 \uc5b4\ub5bb\uac8c \uc900\ube44\ud574\uc57c \ud558\ub294\uc9c0\ub97c \ud55c \uc2dc\uac04 \ub3d9\uc548 \ud568\uaed8 \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc6e8\ube44\ub098 \uac1c\uc694<\/h2>\n\n\n\n
\uc77c\uc2dc<\/th>2026\ub144 11\uc6d4 10\uc77c(\ud654) \uc624\ud6c4 2\uc2dc~3\uc2dc (\ubbf8\uad6d \ub3d9\ubd80\uc2dc\uac04)<\/th><\/tr><\/thead>
\ud55c\uad6d \uc2dc\uac04<\/td>2026\ub144 11\uc6d4 11\uc77c(\uc218) \uc624\uc804 4\uc2dc~5\uc2dc<\/td><\/tr>
\ud615\uc2dd<\/td>\uc628\ub77c\uc778 \uc6e8\ube44\ub098 (GoToWebinar), \uc601\uc5b4 \uc9c4\ud589<\/td><\/tr>
\uacf5\ub3d9 \uc8fc\ucd5c<\/td>Amin Wasserman Gurnani(AWG), \ud55c\uc0d8\uae00\ub85c\ubc8c<\/td><\/tr>
\ucc38\uac00 \uc2e0\uccad<\/td>https:\/\/register.gotowebinar.com\/register\/3566545699040380768<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

\uc65c \uc774 \uc6e8\ube44\ub098\uc778\uac00<\/h2>\n\n\n\n

\ubbf8\uad6d\uc740 \uc758\ub8cc\uae30\uae30 \ubd84\uc57c\uc5d0\uc11c \uacbd\uc7c1\uc774 \uac00\uc7a5 \uce58\uc5f4\ud558\uace0 \uaddc\uc81c\uac00 \uc5c4\uaca9\ud55c \uc2dc\uc7a5 \uc911 \ud558\ub098\uc785\ub2c8\ub2e4. \uc81c\ud488 \uc790\uccb4\uc758 \ud488\uc9c8\uc774 \uc6b0\uc218\ud558\ub354\ub77c\ub3c4 \ubb38\uc11c\uac00 \ubbf8\ube44\ud558\uac70\ub098 \uaddc\uc81c \uc694\uac74\uc744 \uc798\ubabb \uc774\ud574\ud574 \ucd9c\uc2dc\uac00 \ub2a6\uc5b4\uc9c0\uace0 \ube44\uc6a9\uc774 \ub298\uc5b4\ub098\ub294 \uacbd\uc6b0\uac00 \uc801\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ud754\ud788 “FDA \uc778\uc99d”\uc774\ub77c\uace0 \ubd80\ub974\ub294 \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\uc785 \uc808\ucc28\uc5d0\ub294 \uc2dc\ud310 \uc804 \uc81c\ucd9c\ubfd0 \uc544\ub2c8\ub77c \ud488\uc9c8\uc2dc\uc2a4\ud15c, \uc2dc\uc124 \ub4f1\ub85d, \ub77c\ubca8\ub9c1 \ub4f1 \uc5ec\ub7ec \uaddc\uc81c\uac00 \ud568\uaed8 \uc801\uc6a9\ub418\uba70, \ud574\uc678 \uc81c\uc870\uc0ac\ub3c4 \ubbf8\uad6d \uc81c\uc870\uc0ac\uc640 \uac19\uc740 \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774\ubc88 \uc6e8\ube44\ub098\ub294 \uc774\ub7ec\ud55c \uc694\uac74\uc774 \uc5b4\ub5a4 \uacbd\uc6b0\uc5d0 \uc5b4\ub5bb\uac8c \uc801\uc6a9\ub418\ub294\uc9c0 \uc2e4\ubb34 \uad00\uc810\uc5d0\uc11c \uc815\ub9ac\ud558\uace0, \uc77c\uc815\uacfc \ub9ac\uc2a4\ud06c\ub97c \uad00\ub9ac\ud558\uba70 \uaddc\uc81c \ub2f9\uad6d\uc758 \uc9c0\uc801\uc744 \uc904\uc774\uae30 \uc704\ud55c \uc804\ub7b5\uc744 \uc18c\uac1c\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc8fc\uc694 \ub0b4\uc6a9<\/h2>\n\n\n\n

AWG \ubc1c\ud45c: FDA \uaddc\uc81c \uc694\uac74<\/h4>\n\n\n\n
    \n
  1. \uc758\ub8cc\uae30\uae30 \uc2dc\ud310 \uc804 \uc81c\ucd9c (510(k) \ub4f1 Premarket Submissions)<\/li>\n\n\n\n
  2. \ud488\uc9c8\uad00\ub9ac\uc2dc\uc2a4\ud15c \uaddc\uc815 (QMSR)<\/li>\n\n\n\n
  3. \uc2dc\uc124 \ub4f1\ub85d \ubc0f \uae30\uae30 \ub4f1\uc7ac (Establishment Registration & Listing)<\/li>\n\n\n\n
  4. \uc758\ub8cc\uae30\uae30 \ubcf4\uace0 (Medical Device Reporting)<\/li>\n<\/ol>\n\n\n\n

    \ud55c\uc0d8\uae00\ub85c\ubc8c \ubc1c\ud45c: <\/strong>\uc2b9\uc778 \uc694\uac74\uc744 \uac16\ucd98 IFU \uac1c\ubc1c<\/h4>\n\n\n\n

    \uc0ac\uc6a9\uc124\uba85\uc11c\uc640 \ub77c\ubca8\ub9c1\uc740 FDA \uaddc\uc81c \uc694\uac74\uc774 \uc2e4\uc81c\ub85c \ub2f4\uae30\ub294 \ubb38\uc11c\uc785\ub2c8\ub2e4. \ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \uc758\ub8cc\uae30\uae30\ub97c \ud3ec\ud568\ud55c \ubaa8\ub4e0 \uc0b0\uc5c5\uad70\uc758 \uc0ac\uc6a9\uc124\uba85\uc11c\uc5d0 \uacf5\ud1b5\uc73c\ub85c \uc801\uc6a9\ub418\ub294 \uad6d\uc81c\ud45c\uc900 IEC\/IEEE 82079-1\uc5d0 \ub530\ub978 \uc0ac\uc6a9\uc790 \uc911\uc2ec IFU \uc124\uacc4, ANSI Z535.6\uc5d0 \uae30\ubc18\ud55c \uc548\uc804\uacbd\uace0 \uc791\uc131 \uc6d0\uce59, \uadf8\ub9ac\uace0 21 CFR 801 \ub77c\ubca8\ub9c1 \uc694\uac74\uacfc UDI \ub4f1 FDA \uaddc\uc81c \ub0b4\uc6a9\uc744 IFU\uc5d0 \ubc18\uc601\ud558\ub294 \ubc29\ubc95\uc744 \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

    \uc774\ub7f0 \ubd84\ub4e4\uaed8 \uad8c\ud569\ub2c8\ub2e4<\/h2>\n\n\n\n
      \n
    1. \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \ucc98\uc74c \uc900\ube44\ud558\uac70\ub098 \ud655\ub300\ud558\ub824\ub294 \uc911\uc18c\u00b7\uc911\uacac \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac<\/li>\n\n\n\n
    2. FDA \uc778\ud5c8\uac00(RA) \uc5c5\ubb34\ub97c \ub9e1\uace0 \uc788\ub294 \ub2f4\ub2f9\uc790<\/li>\n\n\n\n
    3. \ud574\uc678 \uc601\uc5c5\u00b7\uc0ac\uc5c5\uac1c\ubc1c \ub2f4\ub2f9\uc790\uc640 \uae30\uc220\ubb38\uc11c\u00b7\uc0ac\uc6a9\uc124\uba85\uc11c \ub2f4\ub2f9\uc790<\/li>\n\n\n\n
    4. \ud604\uc7ac\uc758 \ubbf8\uad6d \uc9c4\ucd9c \uc804\ub7b5\uacfc \ubb38\uc11c \uc900\ube44 \uc0c1\ud0dc\ub97c \uc810\uac80\ud558\uace0 \uc2f6\uc740 \uacbd\uc601\uc9c4<\/li>\n<\/ol>\n\n\n\n

      \ubc1c\ud45c\uc790<\/h2>\n\n\n\n

      Neil O’Flaherty<\/strong> | Amin Wasserman Gurnani \ud30c\ud2b8\ub108 \ubcc0\ud638\uc0ac<\/h4>\n\n\n\n

      36\ub144 \uc774\uc0c1 \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uc744 \ub300\ub9ac\ud574 \uc628 FDA \uaddc\uc81c \uc804\ubb38 \ubcc0\ud638\uc0ac\ub85c, Class I\u00b7II\u00b7III \uc758\ub8cc\uae30\uae30\uc758 \uc2dc\ud310 \uc804 \ub2e8\uacc4\ubd80\ud130 \uc0c1\uc5c5\ud654 \uc774\ud6c4\uae4c\uc9c0 \ub2e4\uad6d\uc801 \uae30\uc5c5\uacfc \uc2a4\ud0c0\ud2b8\uc5c5\uc5d0 \uc790\ubb38\ud574 \uc654\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

      Brian Cho<\/strong> | \ud55c\uc0d8\uae00\ub85c\ubc8c Managing Director, PMP<\/h4>\n\n\n\n

      \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uc774 \ubbf8\uad6d\uacfc \ud574\uc678 \uc2dc\uc7a5\uc5d0 \ub9de\ub294 \uba85\ud655\ud558\uace0 \uc815\ud655\ud55c \ubb38\uc11c\ub97c \uc900\ube44\ud558\ub3c4\ub85d \uc9c0\uc6d0\ud558\uba70, \uae00\ub85c\ubc8c \uc81c\ud488 \ucd9c\uc2dc \uacfc\uc815\uc5d0\uc11c \ubb38\uc11c \ud488\uc9c8\uacfc \ud604\uc9c0\ud654, \uaddc\uc81c \uc694\uac74\uc774 \uc5b4\ub5bb\uac8c \ub9de\ubb3c\ub9ac\ub294\uc9c0\uc5d0 \ub300\ud55c \uc2e4\ubb34 \uad00\uc810\uc744 \uc804\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

      \ucc38\uac00 \uc2e0\uccad<\/h2>\n\n\n\n

      \uc6e8\ube44\ub098\ub294 \uc601\uc5b4\ub85c \uc9c4\ud589\ub418\uba70 \uc544\ub798 \ub9c1\ud06c\uc5d0\uc11c \uc0ac\uc804 \ub4f1\ub85d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

      \ucc38\uac00 \uc2e0\uccad\ud558\uae30: https:\/\/register.gotowebinar.com\/register\/3566545699040380768<\/a><\/p>\n\n\n\n

      AWG \uc6e8\ube44\ub098 \uc548\ub0b4 \ud398\uc774\uc9c0: https:\/\/awglaw.com\/events\/how-to-get-it-right-legally-launch-a-medical-device-in-the-u-s\/<\/a><\/p>\n\n\n\n

      <\/p>\n","protected":false},"featured_media":14188,"parent":0,"menu_order":0,"template":"","blog-types":[125],"class_list":["post-14190","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog-types-translationlocalization-ko"],"acf":[],"yoast_head":"\n\uc758\ub8cc\uae30\uae30 \ubbf8\uad6d FDA \uc9c4\ucd9c \uc6e8\ube44\ub098, IFU\uc640 \ub77c\ubca8\ub9c1 \uc694\uac74\uae4c\uc9c0<\/title>\n<meta name=\"description\" content=\"\ud55c\uc0d8\uae00\ub85c\ubc8c\uacfc \ubbf8\uad6d FDA \uaddc\uc81c \uc804\ubb38 \ub85c\ud38c AWG\uac00 11\uc6d4 10\uc77c \uc758\ub8cc\uae30\uae30 \ubbf8\uad6d \ucd9c\uc2dc \uc6e8\ube44\ub098\ub97c \uacf5\ub3d9 \uac1c\ucd5c\ud569\ub2c8\ub2e4. FDA \uc778\ud5c8\uac00 \uc694\uac74\uacfc IFU\u00b7\ub77c\ubca8\ub9c1 \uc791\uc131 \uc6d0\uce59\uc744 \uc18c\uac1c\ud569\ub2c8\ub2e4.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hansem.com\/ko\/blog\/fda-medical-device-ifu-webinar-ko\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\uc758\ub8cc\uae30\uae30 \ubbf8\uad6d FDA \uc9c4\ucd9c \uc6e8\ube44\ub098, IFU\uc640 \ub77c\ubca8\ub9c1 \uc694\uac74\uae4c\uc9c0\" \/>\n<meta property=\"og:description\" content=\"\ud55c\uc0d8\uae00\ub85c\ubc8c\uacfc \ubbf8\uad6d FDA \uaddc\uc81c \uc804\ubb38 \ub85c\ud38c AWG\uac00 11\uc6d4 10\uc77c \uc758\ub8cc\uae30\uae30 \ubbf8\uad6d \ucd9c\uc2dc \uc6e8\ube44\ub098\ub97c \uacf5\ub3d9 \uac1c\ucd5c\ud569\ub2c8\ub2e4. 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