{"id":10053,"date":"2026-06-16T08:30:00","date_gmt":"2026-06-15T23:30:00","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&p=10053"},"modified":"2026-06-15T09:55:57","modified_gmt":"2026-06-15T00:55:57","slug":"%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-%eb%b6%81%eb%af%b8%ec%88%98%ec%b6%9c-ifu-%ea%b7%9c%ec%a0%9c","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-%eb%b6%81%eb%af%b8%ec%88%98%ec%b6%9c-ifu-%ea%b7%9c%ec%a0%9c\/","title":{"rendered":"\ub9e4\ub274\uc5bc\uacfc \uaddc\uc81c \u2014 Part 2. \ud5ec\uc2a4\ucf00\uc5b4 & \uc758\ub8cc\uae30\uae30"},"content":{"rendered":"\n

\uc758\ub8cc\uae30\uae30\uc5d0\uc11c \uc0ac\uc6a9\uc790\uc6a9 \ub9e4\ub274\uc5bc\uc740 \uaddc\uc81c\uc0c1 IFU(Instructions for Use)\ub85c \ubd88\ub9bd\ub2c8\ub2e4. IFU\ub294 \ubd81\ubbf8 \uc2dc\uc7a5 \uc9c4\ucd9c\uc5d0\uc11c \uc81c\ud488 \uc778\uc99d, \ub77c\ubca8\ub9c1, \uc0ac\uc6a9\uc131 \ud3c9\uac00\uc640 \uc9c1\uc811 \uc5f0\uacb0\ub418\ub294 \ud575\uc2ec \uaddc\uc81c \ubb38\uc11c\uc785\ub2c8\ub2e4. \uc774 \uae00\uc5d0\uc11c\ub294 \ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 FDA 510(k), Health Canada, MDSAP \ub300\uc751 \uacfc\uc815\uc5d0\uc11c \uc790\uc8fc \ub9c8\uc8fc\ud558\ub294 IFU\u00b7\ub77c\ubca8\ub9c1 \ubb38\uc81c\ub97c \uc9da\uace0, \uaddc\uc81c \uc804\ub7b5\uacfc \ubb38\uc11c \uc81c\uc791\uc744 \ud568\uaed8 \uad00\ub9ac\ud574\uc57c \ud558\ub294 \uc774\uc720\ub97c \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

“\uc81c\ud488\uc740 \ud1b5\uacfc\ud588\ub294\ub370, \ub9e4\ub274\uc5bc \ub54c\ubb38\uc5d0 \ub2a6\uc5b4\uc9c8 \uac83 \uac19\uc2b5\ub2c8\ub2e4”<\/h3>\n\n\n\n

\uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 \ubbf8\uad6d FDA 510(k) \uc2ec\uc0ac\ub97c \uc2e0\uccad\ud55c \ub4a4 \uac00\uc7a5 \uc790\uc8fc \ub4e3\ub294 \uc18c\uc2dd\uc774 \uc788\uc2b5\ub2c8\ub2e4. “\ucd94\uac00 \uc815\ubcf4 \uc694\uccad(Additional Information Request)\uc774 \uc654\uc2b5\ub2c8\ub2e4.” 510(k) \uc2ec\uc0ac \ud3c9\uade0 \uc18c\uc694 \uae30\uac04\uc740 6~9\uac1c\uc6d4\uc774\uc9c0\ub9cc, \ucd94\uac00 \uc694\uccad\uc774 \ud55c \ubc88 \ub4e4\uc5b4\uc624\uba74 1\ub144 \uc774\uc0c1\uc73c\ub85c \ub298\uc5b4\ub0a9\ub2c8\ub2e4.<\/p>\n\n\n\n

\ucd94\uac00 \uc694\uccad\uc758 \uac00\uc7a5 \ud754\ud55c \uc6d0\uc778\uc774 \ubb34\uc5c7\uc77c\uae4c\uc694. \uc81c\ud488\uc758 \uc548\uc804\uc131\u00b7\uc131\ub2a5 \ubb38\uc81c\uc77c \uac83 \uac19\uc9c0\ub9cc \uadf8\ub807\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. IFU(\uc0ac\uc6a9\uc124\uba85\uc11c)\uc640 \ub77c\ubca8\ub9c1\uc758 \uc815\ud569\uc131 \ubb38\uc81c<\/strong>\uac00 \uc555\ub3c4\uc801\uc73c\ub85c \ub9ce\uc2b5\ub2c8\ub2e4. IFU\uc5d0 \ub204\ub77d\ub41c \uc548\uc804 \uacbd\uace0, \ub77c\ubca8\uacfc IFU\uc758 \uc704\ud5d8 \uc815\ubcf4 \ubd88\uc77c\uce58, ISO 15223-1 \uc2ec\ubcfc \uc624\uc6a9, IEC 62366-1 \uc0ac\uc6a9\uc131 \ud3c9\uac00 \uacb0\uacfc\uac00 IFU\uc5d0 \ubc18\uc601\ub418\uc9c0 \uc54a\uc740 \uacbd\uc6b0, IFU \uac00\ub3c5\uc131 \ubbf8\ud761 \ub4f1\uc774 \ub300\ud45c\uc801\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774\uc804 \ud3b8\uc5d0\uc11c \ub2e4\ub8ec “\ub9e4\ub274\uc5bc\uc740 \uaddc\uc81c \uc2ec\uc0ac\uc758 \uc9c1\uc811 \ub300\uc0c1”\uc774\ub77c\ub294 \uc0ac\uc2e4\uc774 \uac00\uc7a5 \ucca8\uc608\ud558\uac8c \uc791\ub3d9\ud558\ub294 \uc601\uc5ed\uc774 \ubc14\ub85c \uc758\ub8cc\uae30\uae30\uc785\ub2c8\ub2e4. \uc774 \ud3b8\uc740 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 \ubd81\ubbf8 \uc2dc\uc7a5 \uc9c4\ucd9c \uc2dc \ub9c8\uc8fc\ud558\ub294 \ub9e4\ub274\uc5bc \uaddc\uc81c \uc88c\ud45c\ub97c \uc815\ub9ac\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc65c \ubd81\ubbf8\uc778\uac00 \u2014 \ud55c\uad6d \uc81c\uc870\uc0ac\uc758 \uc2e4\uc81c \uc9c4\ucd9c \uc6b0\uc120\uc21c\uc704<\/h3>\n\n\n\n

EU MDR\uc774 \uac15\ud654\ub418\uba74\uc11c \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac \ub2e4\uc218\uac00 EU \uc9c4\ucd9c\uc744 \ubcf4\ub958\ud558\uac70\ub098 \ud6c4\uc21c\uc704\ub85c \ubbf8\ub8e8\uace0 \uc788\uc2b5\ub2c8\ub2e4. EU MDR\uc758 24\uac1c \uc774\uc0c1 \uc5b8\uc5b4 IFU \uc758\ubb34, Notified Body \uc2ec\uc0ac \uc9c0\uc5f0(2~3\ub144 \ub300\uae30), \ud68c\uc6d0\uad6d\ubcc4 PRRC(Person Responsible for Regulatory Compliance) \uc9c0\uc815 \uac19\uc740 \uc9c4\uc785 \ube44\uc6a9\uc774 \ubd80\ub2f4\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubc18\uba74 \ubbf8\uad6d\uc740 \ub2e8\uc77c \uaddc\uc81c \ub2f9\uad6d(FDA), \uc601\uc5b4 \ub2e8\uc77c IFU, \uba85\ud655\ud55c 510(k) \uc808\ucc28\ub85c \uc9c4\uc785 \ube44\uc6a9\uc774 \uc0c1\ub300\uc801\uc73c\ub85c \ub0ae\uc2b5\ub2c8\ub2e4. \uc2dc\uc7a5 \uaddc\ubaa8\ub294 \ub2e8\uc77c \uad6d\uac00 \uae30\uc900 \uc138\uacc4 \ucd5c\ub300\ub85c, \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 \uac00\uc7a5 \uba3c\uc800 \uc9c4\ucd9c\uc744 \uc2dc\ub3c4\ud558\ub294 \uc2dc\uc7a5\uc785\ub2c8\ub2e4. \uce90\ub098\ub2e4 Health Canada\ub294 \ubbf8\uad6d \uc9c4\ucd9c\uc5d0 \ubd80\uc18d\ud574\uc11c \ub530\ub77c\uc624\ub294 \uacbd\uc6b0\uac00 \ub9ce\uace0, MDSAP(Medical Device Single Audit Program)\ub97c \ud65c\uc6a9\ud558\uba74 \ubbf8\uad6d\u00b7\uce90\ub098\ub2e4\u00b7\ud638\uc8fc\u00b7\ube0c\ub77c\uc9c8\u00b7\uc77c\ubcf8 5\uac1c\uad6d \uc2dc\uc7a5\uc774 \ub3d9\uc2dc\uc5d0 \uc5f4\ub9bd\ub2c8\ub2e4.<\/p>\n\n\n\n

\ud56d\ubaa9<\/th>\ubbf8\uad6d (FDA)<\/th>\uce90\ub098\ub2e4 (Health Canada)<\/th>EU (MDR)<\/th><\/tr><\/thead>
\uaddc\uc81c \ub2f9\uad6d<\/td>\ub2e8\uc77c (FDA)<\/td>Health Canada<\/td>\ud68c\uc6d0\uad6d\ubcc4 + Notified Body<\/td><\/tr>
IFU \uc5b8\uc5b4<\/td>\uc601\uc5b4 \ub2e8\uc77c<\/td>\uc601\uc5b4\u00b7\ud504\ub791\uc2a4\uc5b4 \uc774\uc911 \uc5b8\uc5b4
(\ubc95\uc801 \uc758\ubb34)<\/td>		24\uac1c \uc774\uc0c1 \uc5b8\uc5b4 \uc758\ubb34<\/td><\/tr>
\uc2dc\ud310 \uc804 \uc808\ucc28<\/td>510(k) \/ De Novo<\/td>\ub77c\uc774\uc120\uc2a4 \uc2e0\uccad (SOR\/98-282)<\/td>Notified Body \uc801\ud569\uc131 \ud3c9\uac00<\/td><\/tr>
\uc2ec\uc0ac \uae30\uac04<\/td>510(k) \ud3c9\uade0 6~9\uac1c\uc6d4
(\ucd94\uac00 \uc694\uccad \uc2dc 1\ub144+)<\/td>		\ubbf8\uad6d \uc9c4\ucd9c\uc5d0 \ubd80\uc18d \uc9c4\ud589<\/td>NB \uc2ec\uc0ac 2~3\ub144 \ub300\uae30<\/td><\/tr>
\uc9c4\uc785 \ube44\uc6a9<\/td>\uc0c1\ub300\uc801\uc73c\ub85c \ub0ae\uc74c<\/td>\ub0ae\uc74c<\/td>\ub192\uc74c (PRRC \uc9c0\uc815 \ub4f1)<\/td><\/tr>
\ub2e4\uad6d\uac00 \ud655\uc7a5<\/td>MDSAP\ub85c \ubbf8\u00b7\uce90\u00b7\ud638\u00b7\ube0c\u00b7\uc77c 5\uac1c\uad6d \ub3d9\uc2dc<\/td>MDSAP \uc801\uc6a9 \uac00\ub2a5<\/td>\ud574\ub2f9 \uc5c6\uc74c<\/td><\/tr><\/tbody><\/table>
\ud45c 1. \ubbf8\uad6d\u00b7\uce90\ub098\ub2e4\u00b7EU \uc758\ub8cc\uae30\uae30 IFU \uaddc\uc81c \ube44\uad50<\/figcaption><\/figure>\n\n\n\n

Class IIb \uc758\ub8cc\uae30\uae30\uc5d0 \uc801\uc6a9\ub418\ub294 \ud575\uc2ec \uaddc\uc81c<\/h3>\n\n\n\n

\ud55c\uad6d \uc2dd\uc57d\ucc98 3\ub4f1\uae09, \ubbf8\uad6d FDA Class II \uc0c1\uc704, EU MDR Class IIb\uc5d0 \ud574\ub2f9\ud558\ub294 \uc758\ub8cc\uae30\uae30 \u2014 \uc2e0\uc0dd\uc544 \uc758\ub8cc\uae30\uae30, \uc778\uacf5\ud638\ud761\uae30\u00b7\ub9c8\ucde8\uae30, X-ray\u00b7CT\u00b7\uc9c4\ub2e8 \ucd08\uc74c\ud30c, \ud22c\uc11d\uae30, \ubbf8\uc6a9 \uc758\ub8cc\uae30\uae30(HIFU\u00b7\ub808\uc774\uc800), \ud658\uc790 \ubaa8\ub2c8\ud130\ub9c1 \uc2dc\uc2a4\ud15c \ub4f1 \u2014 \uc758 IFU\u00b7\ub77c\ubca8\ub9c1\uc5d0\ub294 \ub2e4\uc74c \uaddc\uc81c\uac00 \uc9c1\uc811 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubbf8\uad6d FDA.<\/strong> \uc2dc\ud310 \uc804 \uc808\ucc28\ub294 510(k) Premarket Notification<\/strong> \ub610\ub294 De Novo Classification Request<\/strong>\uc785\ub2c8\ub2e4. \ub77c\ubca8\ub9c1 \uaddc\uc815\uc740 21 CFR Part 801<\/strong>, UDI(Unique Device Identification) \uc2dc\uc2a4\ud15c\uc740 21 CFR Part 830<\/strong>\uc774 \uaddc\uc815\ud569\ub2c8\ub2e4. eIFU(\uc804\uc790 \uc0ac\uc6a9\uc124\uba85\uc11c)\ub294 21 CFR 801.109\uc5d0 \ub530\ub77c \uc804\ubb38\uac00\uc6a9 \uc758\ub8cc\uae30\uae30\uc5d0 \ud55c\ud574 \uc870\uac74\ubd80 \ud5c8\uc6a9\ub418\uba70 \ud5c8\uc6a9 \ubc94\uc704\uac00 \uc9c0\uc18d \ud655\ub300 \uc911\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

\uce90\ub098\ub2e4 Health Canada.<\/strong> Medical Devices Regulations(SOR\/98-282) \uc801\uc6a9. \ud55c\uad6d 3\ub4f1\uae09\uc5d0 \ub300\uc751\ud558\ub294 \uce90\ub098\ub2e4 Class III\ub294 \ub77c\uc774\uc120\uc2a4 \uc2e0\uccad \uc2dc \uc601\uc5b4\u00b7\ud504\ub791\uc2a4\uc5b4 \uc774\uc911 \uc5b8\uc5b4 IFU\uac00 \ubc95\uc801 \uc758\ubb34\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubcf4\uc870 \ud45c\uc900.<\/strong> \uc0ac\uc6a9\uc131 \uacf5\ud559 IEC 62366-1<\/strong>, \uc704\ud5d8\uad00\ub9ac ISO 14971<\/strong>, \uc758\ub8cc\uae30\uae30 \uc2ec\ubcfc ISO 15223-1<\/strong>, \uc81c\uc870\uc790 \uc81c\uacf5 \uc815\ubcf4 ISO 20417<\/strong>, \uc804\uae30 \uc758\ub8cc\uae30\uae30 \uae30\ubcf8 \uc548\uc804 IEC 60601-1<\/strong> \uc2dc\ub9ac\uc988, \uc815\ubcf4\ud1b5\uc2e0 \uc548\uc804 IEC\/IEEE 82079-1<\/strong>\uc774 \ub3d9\ubc18 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc601\uc0c1 \uc9c4\ub2e8(X-ray\u00b7CT)\uacfc \ubbf8\uc6a9 \uc758\ub8cc\uae30\uae30\ub294 IEC 60601-2 \uc2dc\ub9ac\uc988<\/strong>\uc758 \ud574\ub2f9 \ubd80\ubd84 \uaddc\uaca9\uc774 \ucd94\uac00\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

IFU\uc5d0\uc11c \uc790\uc8fc \uad00\ucc30\ub418\ub294 \ubb38\uc81c<\/h3>\n\n\n\n

\ud55c\uad6d \uc81c\uc870\uc0ac\uac00 FDA 510(k) \uc2ec\uc0ac \uacfc\uc815\uc5d0\uc11c \uc790\uc8fc \ub9c8\uc8fc\ud558\ub294 IFU\u00b7\ub77c\ubca8\ub9c1 \uad00\ub828 \uc9c0\uc801\uc0ac\ud56d\uc73c\ub85c\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \uc720\ud615\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uc911 \ub2e4\uc218\ub294 IFU \uc791\uc131 \ub2e8\uacc4\uc5d0\uc11c \uc810\uac80\ub418\uc9c0 \uc54a\uace0 \uc778\uc99d \uc2ec\uc0ac \ub2e8\uacc4\uc5d0 \uac00\uc11c\uc57c \ubc1c\uacac\ub418\uba70, \uadf8 \uc2dc\uc810\uc5d0 \ubc1c\uacac\ub418\uba74 IFU \uc7ac\uc791\uc131\u00b7\uc7ac\uc81c\ucd9c\ub85c \ucd9c\uc2dc \uc77c\uc815\uc774 \uc0c1\ub2f9 \uae30\uac04 \uc5f0\uc7a5\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc704\ud5d8\uad00\ub9ac \ud30c\uc77c\uacfc IFU\uc758 \ubd88\uc77c\uce58<\/strong>. ISO 14971\uc5d0 \ub530\ub77c \uc2dd\ubcc4\ub41c \uc704\ud5d8\uc774 IFU\uc758 \uc548\uc804 \uacbd\uace0\uc5d0 \ubc18\uc601\ub418\uc9c0 \uc54a\uac70\ub098, \uc77c\ubd80 \uc704\ud5d8\ub9cc \ubc18\uc601\ub418\ub294 \uacbd\uc6b0. \uc704\ud5d8\uad00\ub9ac \ud30c\uc77c\uc740 RA \ubd80\uc11c\uac00, IFU\ub294 \ub9e4\ub274\uc5bc \ubd80\uc11c\uac00 \uc791\uc131\ud558\uba74\uc11c \ub450 \ubb38\uc11c \uac04\uc758 \uc815\ud569\uc131\uc774 \uc810\uac80\ub418\uc9c0 \uc54a\uc740 \uacb0\uacfc\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

\ub77c\ubca8\uacfc IFU\uc758 \uc704\ud5d8 \uc815\ubcf4 \ucc28\uc774<\/strong>. \ub77c\ubca8\uc5d0\ub294 \uc788\ub294 \uacbd\uace0\uac00 IFU\uc5d0\ub294 \ub204\ub77d\ub418\uac70\ub098, \ubc18\ub300\ub85c IFU\uc758 \uc0ac\uc6a9 \uc870\uac74\uc774 \ub77c\ubca8 \ud45c\uae30\uc640 \ub2e4\ub978 \uacbd\uc6b0.<\/p>\n\n\n\n

ISO 15223-1 \uc2ec\ubcfc \uc624\uc6a9<\/strong>. \uba78\uade0 \ud45c\uc2dc, \ub2e8\uc77c \uc0ac\uc6a9 \ud45c\uc2dc, \uc720\ud6a8\uae30\uac04 \ud45c\uae30 \uac19\uc740 \ud45c\uc900 \uc2ec\ubcfc\uc774 ISO 15223-1 \uaddc\uc815\uacfc \ub2e4\ub974\uac8c \uc0ac\uc6a9\ub418\uac70\ub098, IFU\uc5d0 \uc0ac\uc6a9\ub41c \uc2ec\ubcfc\uc758 \uc758\ubbf8\ub97c \uc124\uba85\ud558\ub294 Symbol Glossary\uac00 \ub204\ub77d\ub418\ub294 \uacbd\uc6b0.<\/p>\n\n\n\n

IEC 62366-1 \uc0ac\uc6a9\uc131 \ud3c9\uac00 \uacb0\uacfc\uc758 IFU \ubbf8\ubc18\uc601<\/strong>. \uc0ac\uc6a9\uc131 \ud3c9\uac00\uc5d0\uc11c \uc2dd\ubcc4\ub41c \uc0ac\uc6a9\uc790 \uc624\ub958 \uac00\ub2a5\uc131\uc774 IFU\uc758 \uc0ac\uc6a9 \uc808\ucc28\u00b7\uacbd\uace0\uc5d0 \ubc18\uc601\ub418\uc9c0 \uc54a\uc740 \uacbd\uc6b0.<\/p>\n\n\n\n

\ud658\uc790\uc6a9 IFU\uc758 \uac00\ub3c5\uc131 \ubbf8\ud761<\/strong>. FDA\ub294 \ud658\uc790\uc6a9 \uc758\ub8cc\uae30\uae30 IFU\uc5d0 \ud658\uc790\uac00 \uc774\ud574\ud560 \uc218 \uc788\ub294 \uc218\uc900\uc758 \ud3c9\uc774\ud55c \uc5b8\uc5b4\ub97c \uad8c\uace0\ud558\uc9c0\ub9cc, \ud55c\uad6d \uc81c\uc870\uc0ac\uc758 \uc601\ubb38 IFU\uac00 \uc9c1\uc5ed\uccb4\ub85c \uc791\uc131\ub418\uc5b4 \uac00\ub3c5\uc131\uc5d0\uc11c \uc9c0\uc801\ubc1b\ub294 \uacbd\uc6b0\uac00 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\ub2e4\uad6d\uc5b4 IFU \uac04\uc758 \uc815\ud569\uc131 \ubb38\uc81c<\/strong>. \uc601\ubb38 \uc6d0\ubcf8\uc5d0\ub294 \uc788\ub294 \uc548\uc804 \uacbd\uace0\uac00 \ub2e4\ub978 \uc5b8\uc5b4 \ubc84\uc804\uc5d0\ub294 \ub204\ub77d\ub418\uac70\ub098 \ud45c\ud604\uc774 \uc57d\ud654\ub41c \uacbd\uc6b0. EU MDR\ucc98\ub7fc \ub2e4\uad6d\uc5b4 IFU \uc815\ud569\uc131\uc774 \uc778\uc99d \uc2ec\uc0ac \ud56d\ubaa9\uc778 \uc2dc\uc7a5\uc5d0\uc11c\ub294 \uc9c1\uc811\uc801\uc778 \uc9c0\uc801\uc0ac\ud56d\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\ud55c\uad6d \uc81c\uc870\uc0ac \ub9e4\ub274\uc5bc \ub2f4\ub2f9\uc790\uac00 \uc790\uc8fc \ub193\uce58\ub294 \uc9c0\uc810<\/h3>\n\n\n\n

\ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uc758 \ub9e4\ub274\uc5bc \uc81c\uc791 \uacfc\uc815\uc5d0\uc11c \uac00\uc7a5 \uc790\uc8fc \uad00\ucc30\ub418\ub294 \uc778\uc2dd \ubb38\uc81c\ub294 \ub2e4\uc74c \uc138 \uac00\uc9c0\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

“\uc704\ud5d8\uad00\ub9ac\ub294 RA \ubd80\uc11c \uc77c”\uc774\ub77c\ub294 \uc778\uc2dd.<\/strong> ISO 14971 \uc704\ud5d8\uad00\ub9ac \ud30c\uc77c\uc740 RA \ubd80\uc11c\uac00 \uc791\uc131\ud558\uc9c0\ub9cc, \uadf8 \uacb0\uacfc\ub97c IFU\uc5d0 \ubc18\uc601\ud558\ub294 \uac83\uc740 \ub9e4\ub274\uc5bc \ubd80\uc11c\uc758 \ucc45\uc784\uc785\ub2c8\ub2e4. \ub450 \ubd80\uc11c \uac04\uc758 \uc815\ubcf4 \uc5f0\uacc4\uac00 \uc5c6\uc73c\uba74 \uc704\ud5d8\uad00\ub9ac \ud30c\uc77c\uacfc IFU \uc0ac\uc774\uc5d0 \uc815\ud569\uc131 \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

“\uc0ac\uc6a9\uc131 \ud3c9\uac00\ub294 \uc784\uc0c1 \uc2dc\ud5d8\uacfc \ub2e4\ub974\ub2e4”\ub294 \uc778\uc2dd.<\/strong> IEC 62366-1 \uc0ac\uc6a9\uc131 \ud3c9\uac00\ub294 \uc0ac\uc6a9\uc790\uac00 IFU\ub97c \ubcf4\uc9c0 \uc54a\uac70\ub098 \uc798\ubabb \uc774\ud574\ud560 \uac00\ub2a5\uc131\uae4c\uc9c0 \uc810\uac80\ud569\ub2c8\ub2e4. \uc774 \uacb0\uacfc\uac00 IFU\u00b7UI \ud14d\uc2a4\ud2b8\u00b7\ub77c\ubca8\uc5d0 \ubc18\uc601\ub418\uc5b4\uc57c \ud558\ub294\ub370, \uc0ac\uc6a9\uc131 \ud3c9\uac00 \uacb0\uacfc\uac00 \ub9e4\ub274\uc5bc \ubd80\uc11c\uc5d0 \uacf5\uc720\ub418\uc9c0 \uc54a\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

“\ubbf8\uad6d \uc2dc\uc7a5\uc740 \uc601\uc5b4\ub9cc \ud558\uba74 \ub41c\ub2e4”\ub294 \uc778\uc2dd.<\/strong> \ubbf8\uad6d\uc740 \uc601\uc5b4 \ub2e8\uc77c\uc774\uc9c0\ub9cc, \uce90\ub098\ub2e4\ub294 \uc601\u00b7\ubd88 \uc774\uc911 \uc5b8\uc5b4, \ubbf8\uad6d \ub0b4 \uc77c\ubd80 \uc2dc\uc7a5(\ud478\uc5d0\ub974\ud1a0\ub9ac\ucf54\u00b7\ud50c\ub85c\ub9ac\ub2e4 \uc77c\ubd80)\uc740 \uc2a4\ud398\uc778\uc5b4 \uc790\ub8cc\uac00 \uc0ac\uc2e4\uc0c1 \ud544\uc218\uc785\ub2c8\ub2e4. MDSAP\ub97c \ud65c\uc6a9\ud558\uba74 5\uac1c\uad6d \ub2e4\uad6d\uc5b4\uac00 \ub3d9\uc2dc\uc5d0 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774 \uc138 \uac00\uc9c0 \uc778\uc2dd \ubb38\uc81c\ub294 \ub9e4\ub274\uc5bc \ubd80\uc11c\uac00 RA\u00b7\uc784\uc0c1\u00b7\uae30\uc220 \ubd80\uc11c\uc640 \ub2e8\uc808\ub418\uc5b4 \uc6b4\uc601\ub420 \ub54c \ubc1c\uc0dd\ud569\ub2c8\ub2e4. \ub9e4\ub274\uc5bc \ubd80\uc11c\uac00 \uc778\uc99d \uc804 \uacfc\uc815\uc5d0 \ucc98\uc74c\ubd80\ud130 \ud1b5\ud569\ub418\uc5b4\uc57c \ud55c\ub2e4\ub294 \uc758\ubbf8\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \ud1b5\ud569 \uc194\ub8e8\uc158 \u2014 AWG\uc640\uc758 \ud30c\ud2b8\ub108\uc2ed<\/h3>\n\n\n\n

\ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 \ubd81\ubbf8 \uc9c4\ucd9c \uc2dc \uc77c\ubc18\uc801\uc73c\ub85c \ub9c8\uc8fc\ud558\ub294 \uc5b4\ub824\uc6c0\uc774 \uc788\uc2b5\ub2c8\ub2e4. FDA \uaddc\uc81c \uc804\ub7b5\uc744 \uc790\ubb38\ud560 \ubbf8\uad6d \ud604\uc9c0 \ucee8\uc124\ud305\uc0ac\uc640 IFU\u00b7\uae30\uc220\ubb38\uc11c\ub97c \uc81c\uc791\ud560 LSP\ub97c \ub530\ub85c \ucc3e\uc544\uc57c \ud558\uace0, \ub450 \ud30c\ud2b8\ub108 \uac04\uc758 \uc815\ubcf4 \uc5f0\uacc4\ub97c \uc9c1\uc811 \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4.<\/strong> \ube44\uc6a9\u00b7\uad00\ub9ac \ubd80\ub2f4\ubfd0 \uc544\ub2c8\ub77c, \ub450 \ud30c\ud2b8\ub108\uc758 \uc0b0\ucd9c\ubb3c \uc0ac\uc774\uc5d0\uc11c \uc815\ud569\uc131 \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud558\uae30 \uc27d\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \uc774 \ubb38\uc81c\uc5d0 \ub300\uc751\ud558\uae30 \uc704\ud574 \ubbf8\uad6d \uc6cc\uc2f1\ud134 D.C. \uc18c\uc7ac \ubc95\ub960\uc0ac\ubb34\uc18c Amin Wasserman Gurnani(AWG)<\/strong> \uc640 \uc804\ub7b5\uc801 \ud30c\ud2b8\ub108\uc2ed\uc744 \uccb4\uacb0\ud588\uc2b5\ub2c8\ub2e4. AWG\ub294 \uc804 FDA \ucd9c\uc2e0 \ubcc0\ud638\uc0ac\uc640 \uacfc\ud559\u00b7\uacf5\ud559 \uc804\ubb38\uac00\ub85c \uad6c\uc131\ub41c \uc758\ub8cc\uae30\uae30 \uaddc\uc81c \uc804\ubb38 \ub85c\ud38c\uc774\uba70, \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 \ubbf8\uad6d \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud560 \ub54c \ub2e4\uc74c\uacfc \uac19\uc774 \ubd84\uc5c5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

    \n
  • AWG<\/strong>: FDA \uc81c\ud488 \ubd84\ub958, 510(k)\u00b7De Novo\u00b7PMA \uc2b9\uc778 \uc804\ub7b5, \ub77c\ubca8\ub9c1\u00b7\uad11\uace0 \ubb38\uad6c \uac80\ud1a0, \uc2dc\ud310 \ud6c4 \uc6b4\uc601 \uaddc\uc81c \uc790\ubb38, FDA \uc2e4\uc0ac \ub300\uc751, \ub9ac\ucf5c\u00b7\ubd84\uc7c1 \ub300\uc751<\/li>\n\n\n\n
  • \ud55c\uc0d8\uae00\ub85c\ubc8c<\/strong>: \ud45c\uc900 \uae30\ubc18\uc758 \uac00\ub3c5\uc131 \ub192\uc740 IFU \uc791\uc131(IEC\/IEEE 82079-1, ANSI Z535.6), \uae30\uc220 \uc77c\ub7ec\uc2a4\ud2b8\ub808\uc774\uc158 \ubc0f \uc2dc\uac01 \ubcf4\uc870\uc7a5\uce58 \uc2dc\uc2a4\ud15c, \ub2e4\uad6d\uc5b4 \ub9e4\ub274\uc5bc \uc81c\uc791(20\uc5ec \uac1c \uc5b8\uc5b4), 21 CFR Part 801\uc758 \ud45c\uc900\ud654\ub41c \ud56d\ubaa9\uc5d0 \ub530\ub978 \ub77c\ubca8\ub9c1 \uc81c\uc791 \u2014 \uaddc\uc81c \uc801\ud569\uc131\uc740 AWG\uc640\uc758 \ud611\uc5c5\uc744 \ud1b5\ud574 \ud655\uc778<\/li>\n<\/ul>\n\n\n\n

    \uc774 \ud1b5\ud569 \uc194\ub8e8\uc158\uc740 \ud55c\uad6d \uc81c\uc870\uc0ac\uac00 \ubcc4\ub3c4\uc758 FDA \ucee8\uc124\ud305\uc0ac\ub97c \ucc3e\uc744 \ud544\uc694 \uc5c6\uc774, \ud55c \ubc88\uc758 \uc758\uc0ac\uacb0\uc815\uc73c\ub85c \uaddc\uc81c \uc804\ub7b5\uacfc \ubb38\uc11c \uc81c\uc791\uc744 \ub3d9\uc2dc\uc5d0 \uc9c4\ud589\ud560 \uc218 \uc788\ub3c4\ub85d \ud569\ub2c8\ub2e4. AWG\uac00 \uaddc\uc81c\uc758 \ubc29\ud5a5\uc744 \uc124\uacc4\ud558\uba74, \ud55c\uc0d8\uae00\ub85c\ubc8c\uc774 \uadf8 \uc804\ub7b5\uc744 \uc0ac\uc6a9\uc790 \uce5c\ud654\uc801\uc774\uace0 \uaddc\uc81c \uc815\ud569\uc131\uc744 \uac16\ucd98 \ubb38\uc11c\ub85c \uc644\uc131\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

    \ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \uc758\ub8cc\uae30\uae30\u00b7\uc0dd\uba85\uacfc\ud559 \uc601\uc5ed \uc6b4\uc601 \uc790\uc0b0\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

      \n
    • ISO 9001(\ud488\uc9c8\uacbd\uc601)\u00b717100(\ubc88\uc5ed \uc11c\ube44\uc2a4)\u00b727001(\uc815\ubcf4\ubcf4\uc548)\u00b718587(MT \ud6c4\ud3b8\uc9d1) 4\uac1c \uad6d\uc81c \uc778\uc99d<\/li>\n\n\n\n
    • GDPR\u00b7HIPAA \ub370\uc774\ud130 \ubcf4\uc548 \uae30\uc900 \ubd80\ud569<\/li>\n\n\n\n
    • ISPOR \uac00\uc774\ub4dc\ub77c\uc778 \uae30\ubc18 Linguistic Validation \uc11c\ube44\uc2a4 (\uc758\ub8cc\uae30\uae30 \uc0ac\uc6a9\uc131 \ud3c9\uac00\u00b7\ud658\uc790 \uc548\ub0b4\ubb38\u00b7eCOA \uc601\uc5ed)<\/li>\n\n\n\n
    • \ubd84\uc790\uc9c4\ub2e8 \uae30\uc5c5 \uc528\uc820\uc758 \uc9c4\ub2e8 \uc2dc\uc57d \ub9e4\ub274\uc5bc 20\uc5ec \uac1c \uc5b8\uc5b4 \ud604\uc9c0\ud654, \uc720\uc804\uc790 \ubd84\uc11d \uae30\uc5c5 \uc778\ube44\ud14c(Invitae)\uc758 200\ub9cc \ub2e8\uc5b4 \uc774\uc0c1 20\uac1c+ \uc5b8\uc5b4 \ud604\uc9c0\ud654, \ubbf8\uad6d \ubc14\uc774\uc624 \uae30\uc5c5 RenovoRX\uc758 \ub9c8\ucf00\ud305 \uc790\ub8cc \uc911\uad6d \uc2dc\uc7a5 \ud604\uc9c0\ud654 \ub4f1 \uae00\ub85c\ubc8c \uc758\ub8cc\u00b7\uc0dd\uba85\uacfc\ud559 \uae30\uc5c5\uacfc\uc758 \ud611\uc5c5 \uacbd\ub825<\/li>\n\n\n\n
    • 2023\ub144 Diversity Alliance for Science(DA4S) \uba58\ud1a0\uc2ed \ud504\ub85c\uadf8\ub7a8 \uc120\uc815. \uc544\uc2a4\ud2b8\ub77c\uc81c\ub124\uce74(AstraZeneca)\ub85c\ubd80\ud130 1\ub144\uac04 \uc0dd\uba85\uacfc\ud559 \ubc88\uc5ed \ubd84\uc57c \ube44\uc988\ub2c8\uc2a4 \uba58\ud1a0\ub9c1 \uc218\ud61c<\/li>\n<\/ul>\n\n\n\n

      \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uc758 \ubd81\ubbf8 \uc9c4\ucd9c\uc740 \uc81c\ud488 \uc778\uc99d\uacfc \ub9e4\ub274\uc5bc \uc81c\uc791\uc774 \ubd84\ub9ac\ub418\uc5b4 \uc788\uc744 \ub54c \uac00\uc7a5 \uc790\uc8fc \uc9c0\uc5f0\ub429\ub2c8\ub2e4. \ub9e4\ub274\uc5bc\uc740 \uc778\uc99d\uc758 \ubd80\uc18d \uc791\uc5c5\uc774 \uc544\ub2c8\ub77c, \uc778\uc99d\uc744 \ud1b5\uacfc\uc2dc\ud0a4\ub294 \ud575\uc2ec \uc790\ub8cc\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

      \uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38 (FAQ)<\/h3>\n\n\n\n

      Q. FDA 510(k) \uc2ec\uc0ac\ub294 \uc5bc\ub9c8\ub098 \uac78\ub9ac\ub098\uc694?<\/strong>
      510(k) \uc2ec\uc0ac \ud3c9\uade0 \uc18c\uc694 \uae30\uac04\uc740 6~9\uac1c\uc6d4\uc785\ub2c8\ub2e4. \ub2e4\ub9cc \ucd94\uac00 \uc815\ubcf4 \uc694\uccad(Additional Information Request)\uc774 \ud55c \ubc88\uc774\ub77c\ub3c4 \ub4e4\uc5b4\uc624\uba74 1\ub144 \uc774\uc0c1\uc73c\ub85c \ub298\uc5b4\ub0a0 \uc218 \uc788\uc73c\uba70, \uadf8 \uac00\uc7a5 \ud754\ud55c \uc6d0\uc778\uc740 \uc81c\ud488\uc758 \uc548\uc804\uc131\u00b7\uc131\ub2a5 \ubb38\uc81c\uac00 \uc544\ub2c8\ub77c IFU(\uc0ac\uc6a9\uc124\uba85\uc11c)\uc640 \ub77c\ubca8\ub9c1\uc758 \uc815\ud569\uc131 \ubb38\uc81c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

      Q. 510(k) \ucd94\uac00 \uc815\ubcf4 \uc694\uccad\uc740 \uc8fc\ub85c \ubb34\uc5c7 \ub54c\ubb38\uc5d0 \ubc1c\uc0dd\ud558\ub098\uc694?<\/strong>
      IFU\uc5d0 \ub204\ub77d\ub41c \uc548\uc804 \uacbd\uace0, \ub77c\ubca8\uacfc IFU \uac04 \uc704\ud5d8 \uc815\ubcf4 \ubd88\uc77c\uce58, ISO 15223-1 \uc2ec\ubcfc \uc624\uc6a9, IEC 62366-1 \uc0ac\uc6a9\uc131 \ud3c9\uac00 \uacb0\uacfc\uc758 IFU \ubbf8\ubc18\uc601, \ud658\uc790\uc6a9 IFU \uac00\ub3c5\uc131 \ubbf8\ud761 \ub4f1 IFU\u00b7\ub77c\ubca8\ub9c1 \uad00\ub828 \uc9c0\uc801\uc774 \ub300\ud45c\uc801\uc785\ub2c8\ub2e4. \uc774 \uc911 \ub2e4\uc218\ub294 IFU \uc791\uc131 \ub2e8\uacc4\uac00 \uc544\ub2c8\ub77c \uc778\uc99d \uc2ec\uc0ac \ub2e8\uacc4\uc5d0\uc11c \ubc1c\uacac\ub418\uc5b4 \ucd9c\uc2dc \uc77c\uc815\uc744 \uc9c0\uc5f0\uc2dc\ud0b5\ub2c8\ub2e4.<\/p>\n\n\n\n

      Q. \ubbf8\uad6d \uc2dc\uc7a5\uc5d0\ub294 IFU\ub97c \uc601\uc5b4\ub85c\ub9cc \uc81c\ucd9c\ud558\uba74 \ub418\ub098\uc694?<\/strong>
      \ubbf8\uad6d\uc740 \uc601\uc5b4 \ub2e8\uc77c IFU\ub85c \ucda9\ubd84\ud558\uc9c0\ub9cc, \uce90\ub098\ub2e4(Health Canada)\ub294 \uc601\uc5b4\u00b7\ud504\ub791\uc2a4\uc5b4 \uc774\uc911 \uc5b8\uc5b4 IFU\uac00 \ubc95\uc801 \uc758\ubb34\uc774\uba70, \ubbf8\uad6d \ub0b4 \uc77c\ubd80 \uc2dc\uc7a5(\ud478\uc5d0\ub974\ud1a0\ub9ac\ucf54\u00b7\ud50c\ub85c\ub9ac\ub2e4 \uc77c\ubd80)\uc740 \uc2a4\ud398\uc778\uc5b4 \uc790\ub8cc\uac00 \uc0ac\uc2e4\uc0c1 \ud544\uc218\uc785\ub2c8\ub2e4. MDSAP\ub97c \ud65c\uc6a9\ud574 \ubbf8\uad6d\u00b7\uce90\ub098\ub2e4\u00b7\ud638\uc8fc\u00b7\ube0c\ub77c\uc9c8\u00b7\uc77c\ubcf8\uc5d0 \ub3d9\uc2dc \uc9c4\ucd9c\ud558\uba74 5\uac1c\uad6d \ub2e4\uad6d\uc5b4 IFU\uac00 \ud568\uaed8 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

      Q. \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\ub294 \uc65c EU\ubcf4\ub2e4 \ubd81\ubbf8\ub97c \uba3c\uc800 \ub178\ub9ac\ub098\uc694?<\/strong>
      EU MDR\uc740 24\uac1c \uc774\uc0c1 \uc5b8\uc5b4 IFU \uc758\ubb34, Notified Body \uc2ec\uc0ac 2~3\ub144 \ub300\uae30, \ud68c\uc6d0\uad6d\ubcc4 PRRC(Person Responsible for Regulatory Compliance) \uc9c0\uc815 \ub4f1 \uc9c4\uc785 \ube44\uc6a9\uc774 \ub192\uc2b5\ub2c8\ub2e4. \ubc18\uba74 \ubbf8\uad6d\uc740 \ub2e8\uc77c \uaddc\uc81c \ub2f9\uad6d(FDA), \uc601\uc5b4 \ub2e8\uc77c IFU, \uba85\ud655\ud55c 510(k) \uc808\ucc28\ub85c \uc9c4\uc785 \ube44\uc6a9\uc774 \uc0c1\ub300\uc801\uc73c\ub85c \ub0ae\uace0, \ub2e8\uc77c \uad6d\uac00 \uae30\uc900 \uc138\uacc4 \ucd5c\ub300 \uc2dc\uc7a5\uc774\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

      Q. eIFU(\uc804\uc790 \uc0ac\uc6a9\uc124\uba85\uc11c)\ub294 \uc5b4\ub5a4 \uacbd\uc6b0\uc5d0 \ud5c8\uc6a9\ub418\ub098\uc694?<\/strong>
      \ubbf8\uad6d\uc5d0\uc11c\ub294 21 CFR 801.109\uc5d0 \ub530\ub77c \uc804\ubb38\uac00\uc6a9 \uc758\ub8cc\uae30\uae30\uc5d0 \ud55c\ud574 \uc870\uac74\ubd80\ub85c \ud5c8\uc6a9\ub418\uba70, \ud5c8\uc6a9 \ubc94\uc704\ub294 \uc9c0\uc18d\uc801\uc73c\ub85c \ud655\ub300\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc77c\ubc18 \ud658\uc790\uc6a9 \uae30\uae30\uc5d0\ub294 \uc5ec\uc804\ud788 \uc81c\ud55c\uc774 \uc788\uc73c\ubbc0\ub85c \ub300\uc0c1 \uae30\uae30\uc758 \ubd84\ub958\uc640 \uc0ac\uc6a9\uc790(\uc804\ubb38\uac00\uc6a9\/\ud658\uc790\uc6a9)\ub97c \uba3c\uc800 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

      Q. \uc704\ud5d8\uad00\ub9ac(ISO 14971)\uc640 IFU\ub294 \uc5b4\ub290 \ubd80\uc11c\uac00 \ucc45\uc784\uc9c0\ub098\uc694?<\/strong>
      ISO 14971 \uc704\ud5d8\uad00\ub9ac \ud30c\uc77c\uc740 RA \ubd80\uc11c\uac00 \uc791\uc131\ud558\uc9c0\ub9cc, \uc2dd\ubcc4\ub41c \uc704\ud5d8\uc744 IFU\uc758 \uc548\uc804 \uacbd\uace0\uc5d0 \ubc18\uc601\ud558\ub294 \uac83\uc740 \ub9e4\ub274\uc5bc \ubd80\uc11c\uc758 \ucc45\uc784\uc785\ub2c8\ub2e4. \ub450 \ubd80\uc11c \uac04 \uc815\ubcf4 \uc5f0\uacc4\uac00 \uc5c6\uc73c\uba74 \uc704\ud5d8\uad00\ub9ac \ud30c\uc77c\uacfc IFU \uc0ac\uc774\uc5d0 \uc815\ud569\uc131 \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud558\ubbc0\ub85c, \ub9e4\ub274\uc5bc \ubd80\uc11c\uac00 \uc778\uc99d \uc804 \uacfc\uc815\uc5d0 \ucc98\uc74c\ubd80\ud130 \ud1b5\ud569\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

      \uc2dc\ub9ac\uc988 \uc608\uace0<\/h3>\n\n\n\n

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