{"id":7543,"date":"2025-07-28T14:35:59","date_gmt":"2025-07-28T05:35:59","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&p=7543"},"modified":"2025-08-07T09:24:01","modified_gmt":"2025-08-07T00:24:01","slug":"%eb%af%b8%ea%b5%ad-%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-%ec%8b%9c%ec%9e%a5-%ec%a7%84%ec%b6%9c-%ea%b0%80%ec%9d%b4%eb%93%9c","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/%eb%af%b8%ea%b5%ad-%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-%ec%8b%9c%ec%9e%a5-%ec%a7%84%ec%b6%9c-%ea%b0%80%ec%9d%b4%eb%93%9c\/","title":{"rendered":"AWG x \ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \ud611\uc5c5 \u2013 FDA \uc2b9\uc778\uc5d0 \ud544\uc694\ud55c IFU \uc791\uc131 \ud575\uc2ec \uac00\uc774\ub4dc"},"content":{"rendered":"\n

\ubbf8\uad6d\uc740 \uc138\uacc4\uc5d0\uc11c \uac00\uc7a5 \ud070 \uc758\ub8cc\uae30\uae30 \uc2dc\uc7a5\uc774\uc790, \uac00\uc7a5 \uae4c\ub2e4\ub85c\uc6b4 \uaddc\uc81c \uc2dc\uc2a4\ud15c\uc744 \uac00\uc9c4 \uad6d\uac00\uc785\ub2c8\ub2e4. \uae30\uc220\ub825\ub9cc\uc73c\ub85c\ub294 \ubd80\uc871\ud569\ub2c8\ub2e4. \uc2e4\uc81c\ub85c \ub9ce\uc740 \uae30\uc5c5\ub4e4\uc774 \uc81c\ud488 \ud488\uc9c8\uc774 \uc544\ub2cc \ubb38\uc11c \ubd88\uc644\uc804<\/strong>\uc774\ub098 \uaddc\uc81c \uc624\ud574<\/strong>\ub85c \uc778\ud574 \uc2b9\uc778 \uc9c0\uc5f0\uc744 \uacaa\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774\uc5d0 \ub530\ub77c \ud55c\uc0d8\uae00\ub85c\ubc8c<\/strong>\uacfc \ubbf8\uad6d FDA \uc804\ubb38 \ub85c\ud38c AWG<\/strong><\/a>\ub294 \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uc758 \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc704\ud574 \uacf5\ub3d9 \uc194\ub8e8\uc158\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \uc758\ub8cc\uae30\uae30 IFU(\uc0ac\uc6a9\uc124\uba85\uc11c) \uc81c\uc791, \ub2e4\uad6d\uc5b4 \uaddc\uc81c \ubb38\uc11c\ud654 \uc5ed\ub7c9<\/strong>\uacfc AWG\uc758 FDA \ubc95\ub960 \uc804\ub7b5 \ubc0f \uaddc\uc81c \ub300\uc751 \uc804\ubb38\uc131<\/strong>\uc744 \uacb0\ud569\ud574, \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc900\ube44\ud558\ub294 \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uc5d0 \ud1b5\ud569\uc801\uc774\uace0 \uc2e4\uc9c8\uc801\uc778 \uc194\ub8e8\uc158\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774 \uae00\uc5d0\uc11c\ub294 \ubbf8\uad6d\uc5d0\uc11c \uc758\ub8cc\uae30\uae30\ub97c \ud569\ubc95\uc801\uc73c\ub85c \ud310\ub9e4\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \ud575\uc2ec \uaddc\uc81c \uc694\uac74\uacfc, \ub2f9\uc0ac\uc758 \ud30c\ud2b8\ub108\uc2ed\uc774 \uc5b4\ub5bb\uac8c \uadc0\uc0ac\uc758 \ubb38\uc11c \ubc0f \ucef4\ud50c\ub77c\uc774\uc5b8\uc2a4 \uc804\ub7b5\uc744 \ucd08\uae30\ubd80\ud130 \uacac\uace0\ud558\uac8c \uad6c\ucd95\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud558\ub294\uc9c0\ub97c \uc18c\uac1c\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubbf8\uad6d FDA \uaddc\uc81c \uc694\uac74: \ubc18\ub4dc\uc2dc \uc900\ube44\ud574\uc57c \ud560 \uc0ac\ud56d<\/h3>\n\n\n\n

\ubbf8\uad6d \ub0b4\uc5d0\uc11c \uc758\ub8cc\uae30\uae30\ub97c \ud310\ub9e4\ud558\ub824\uba74, \ub2e4\uc74c\uacfc \uac19\uc740 \uc8fc\uc694 \uaddc\uc81c\ub97c \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n

    \n
  1. \uc758\ub8cc\uae30\uae30 \ub77c\ubca8\ub9c1 (<\/strong>21 CFR Part 801<\/strong><\/a>)<\/strong>
    \ub77c\ubca8\ub9c1\uc740 \ub2e8\uc21c\ud788 \uc81c\ud488 \uac89\uba74\uc5d0 \ubd99\ub294 \ub77c\ubca8\ub9cc\uc744 \uc758\ubbf8\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc0ac\uc6a9\uc124\uba85\uc11c, \uae08\uae30\uc0ac\ud56d, \uacbd\uace0 \ubc0f \uc8fc\uc758\uc0ac\ud56d \ub4f1\uc744 \ud3ec\ud568\ud558\uba70, \uc601\uc5b4\ub85c \uc791\uc131\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc6f9\uc0ac\uc774\ud2b8, \ube0c\ub85c\uc154, \uc18c\uc15c\ubbf8\ub514\uc5b4 \uac8c\uc2dc\ubb3c\ub3c4 \u2018\ud64d\ubcf4\uc6a9 \ub77c\ubca8\ub9c1\u2019\uc73c\ub85c \uac04\uc8fc\ub420 \uc218 \uc788\uc73c\uba70, \ubd80\uc815\ud655\ud558\uac70\ub098 \ubd88\uc644\uc804\ud55c \ub77c\ubca8\ub9c1\uc740 \uc2b9\uc778  \uc9c0\uc5f0\uc758 \uc8fc\uc694 \uc6d0\uc778\uc774 \ub429\ub2c8\ub2e4. \ub77c\ubca8 \ub0b4\uc758 \uc8fc\uc7a5(claim)\uc740 \uc801\uc808\ud55c \ub370\uc774\ud130\ub85c \ub4b7\ubc1b\uce68\ub418\uc5b4\uc57c \ud558\uba70, \ud574\ub2f9 \uae30\uae30 \uc720\ud615\uc5d0\uc11c \ud5c8\uc6a9 \uac00\ub2a5\ud55c \uc8fc\uc7a5\uc778\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n
  2. \uace0\uc720\uae30\uae30\uc2dd\ubcc4(UDI) (21 CFR Parts 801 & <\/strong>830<\/strong><\/a>)<\/strong>
    \ub300\ubd80\ubd84\uc758 \uae30\uae30 \ubaa8\ub378 \ubc0f \ubc84\uc804\uc740 \ub77c\ubca8\uc5d0 UDI(\uace0\uc720\uae30\uae30\uc2dd\ubcc4\uc790)\ub97c \ud3ec\ud568\ud574\uc57c \ud558\uba70, FDA\uc758 GUDID \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0 \ub4f1\ub85d<\/strong>\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. UDI \ub204\ub77d \ub610\ub294 \ub4f1\ub85d \uc624\ub958<\/strong>\ub294 \uc720\ud1b5 \ubc0f \ub9ac\ucf5c \uad00\ub9ac\uc5d0\uc11c \ud070 \ubb38\uc81c\ub97c \ucd08\ub798\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n
  3. \uc0ac\uc5c5\uc18c \ub4f1\ub85d \ubc0f \uae30\uae30 \ubaa9\ub85d \ub4f1\uc7ac (<\/strong>21 CFR Part 807<\/a>)<\/strong>
    \uc81c\uc870\uc0ac \ubc0f \uad00\ub828 \uc5c5\uccb4\ub294 FDA\uc5d0 \uc0ac\uc5c5\uc18c \ub4f1\ub85d<\/strong>\uc744 \ud558\uace0, \ucde8\uae09 \uae30\uae30 \ubaa9\ub85d\uc744 \ub4f1\uc7ac<\/strong>\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \ub9c8\ucf00\ud305 \uc2dc\uc791 \uc2dc\uc810<\/strong>\uc5d0 \ubc18\ub4dc\uc2dc \uc774\ub8e8\uc5b4\uc838\uc57c \ud558\uba70, \ub9e4\ub144 \uac31\uc2e0<\/strong>\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \ubbf8\uad6d \ub0b4\uc678 \uae30\uc5c5 \ubaa8\ub450\uc5d0\uac8c \uc758\ubb34 \uc0ac\ud56d<\/strong>\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n
  4. \ub9c8\ucf00\ud305 \uc2e0\uccad \uc808\ucc28 (510(k), PMA, De Novo) (21 CFR Parts 807, <\/strong>814<\/a>, <\/strong>860<\/a>)<\/strong>
    \uae30\uae30\uc758 \ub4f1\uae09(Class)\uc5d0 \ub530\ub77c \ud544\uc694\ud55c \uc0ac\uc804 \uc2ec\uc0ac \uc808\ucc28\uac00 \ub2ec\ub77c\uc9d1\ub2c8\ub2e4:

    Class I:<\/strong> \ub300\ubd80\ubd84 \uc0ac\uc804\uc2e0\uace0(510(k)) \uba74\uc81c
    Class II:<\/strong> \uc77c\ubc18\uc801\uc73c\ub85c 510(k) \ub610\ub294 De Novo \uc81c\ucd9c \ud544\uc694
    Class III:<\/strong> PMA(Premarket Approval) \ud544\uc218

    \uac01 \uc808\ucc28\uc5d0\ub294 \ud574\ub2f9 \uae30\uae30\uc758 \uc548\uc804\uc131 \ubc0f \uc720\ud6a8\uc131 \uc785\uc99d \uc790\ub8cc<\/strong>, \uacbd\uc6b0\uc5d0 \ub530\ub77c \uc784\uc0c1\uc2dc\ud5d8 \ub610\ub294 \uc0ac\uc6a9\uc790 \uc778\uc9c0\uc131(human factors)\uc5d0 \ub300\ud55c \uadfc\uac70\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n
  5. \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uaddc\uc815(QSR) (<\/strong>21 CFR Part 820<\/a>)<\/strong>
    FDA\ub294 \uc81c\uc870\uc0ac\uc5d0\uac8c \uc81c\ud488 \uc124\uacc4, \uc0dd\uc0b0, \ud3ec\uc7a5, \ub77c\ubca8\ub9c1, \ubcf4\uad00 \ub4f1 \uc804\ubc18\uc744 \ud3ec\uad04\ud558\ub294 \ud488\uc9c8 \uc2dc\uc2a4\ud15c<\/strong>\uc758 \uad6c\ucd95\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. ISO 13485\uc640 \uc720\uc0ac\ud558\uc9c0\ub9cc FDA \uace0\uc720 \uc694\uac74<\/strong>\uc774 \uc788\uc73c\uba70, 2026\ub144 2\uc6d4\ubd80\ud130\ub294 QSR\uc774     QSMS(Quality System Management Regulation)\ub85c \uc804\ud658<\/a>\ub420 \uc608\uc815\uc785\ub2c8\ub2e4. QSR\uc744 \uc704\ubc18\ud560 \uacbd\uc6b0, FDA\uc758 \uac15\uc81c\uc870\uce58 \ub300\uc0c1<\/strong>\uc774 \ub429\ub2c8\ub2e4.<\/li>\n\n\n\n
  6. \uc758\ub8cc\uae30\uae30 \ubcf4\uace0 \uc694\uac74(MDR) (<\/strong>21 CFR Part 803<\/a>)<\/strong>
    \ud310\ub9e4 \uc774\ud6c4 \ubc1c\uc0dd\ud558\ub294 \uc774\uc0c1 \uc0ac\ub840\uc5d0 \ub300\ud55c \ubcf4\uace0 \ubc0f \uae30\ub85d \uc720\uc9c0<\/strong>\uac00 \ubc95\uc801 \uc758\ubb34\uc785\ub2c8\ub2e4. \uc774\ub97c \uc704\ubc18\ud558\uba74 \uac15\ub825\ud55c \uaddc\uc81c \uc81c\uc7ac<\/strong>\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ol>\n\n\n\n

    Hansem Global \u00d7 AWG, \uc5b4\ub5a4 \uc9c0\uc6d0\uc774 \uac00\ub2a5\ud55c\uac00?<\/h3>\n\n\n\n
    \"\"<\/figure>\n\n\n\n