{"id":1020,"date":"2021-03-03T13:12:14","date_gmt":"2021-03-03T04:12:14","guid":{"rendered":"https:\/\/web.health-life.jp\/kenko-web\/kenko-web\/?p=1020"},"modified":"2021-04-27T15:02:39","modified_gmt":"2021-04-27T06:02:39","slug":"software-as-a-medical-device","status":"publish","type":"post","link":"https:\/\/infoweb.health-life.jp\/kenko-web\/news\/software-as-a-medical-device\/","title":{"rendered":"Software as a Medical Device\uff08SAMD\uff09\u516c\u8868"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>2017\u5e7412\u67088\u65e5\uff08\u91d1\uff09\u306b\u30a2\u30e1\u30ea\u30abFDA \uff08\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u304b\u3089\u3001<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/software-medical-device-samd-clinical-evaluation\" target=\"_blank\" rel=\"noopener\">\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u3064\u3044\u3066\u306e\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\u304c\u767a\u8868\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u3078\u306e\u898f\u5236\u306b\u3064\u3044\u3066\u56fd\u969b\u7684\u306a\u8db3\u4e26\u307f\u3092\u305d\u308d\u3048\u308b\u305f\u3081\u306b\u6d3b\u52d5\u3092\u3057\u3066\u3044\u308bIMDRF\uff08 International Medical Device Regulators Forum \uff09\u306b\u3088\u3063\u3066\u793a\u3055\u308c\u305f\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>FDA\u3092\u6cd5\u7684\u306b\u62d8\u675f\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3068\u306e\u3053\u3068\u3067\u3059\u304c\u3001\u4eca\u5f8cICT\u6280\u8853\u3092\u7528\u3044\u305f\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3059\u308b\u4e8b\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u898f\u5236\u306e\u65b9\u5411\u6027\u3092\u628a\u63e1\u3059\u308b\u4e0a\u3067\u91cd\u8981\u306a\u6307\u91dd\u3068\u306a\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>\u958b\u767a\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u3001\u5f93\u3046\u3079\u304d\u81e8\u5e8a\u306b\u304a\u3051\u308b\u691c\u67fb\u304a\u3088\u3073\u8a55\u4fa1\u306e\u65b9\u5411\u6027\u3092\u4e0e\u3048\u3066\u304f\u308c\u308b\u3082\u306e\u3067\u3042\u308b\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>2013\u5e74\u306bIMDRF\u306b\u3088\u3063\u3066\u4f5c\u6210\u3055\u308c\u305f<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-131209-samd-key-definitions-140901.pdf\" target=\"_blank\" rel=\"noopener\">SaMD N10<\/a> \u3084\u30012014\u5e74\u306e<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf\" target=\"_blank\" rel=\"noopener\">SaMD N12 <\/a>\u00a0\u30012015\u5e74\u306e<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-151002-samd-qms.pdf\" target=\"_blank\" rel=\"noopener\">SaMD N23<\/a> \u3068\u4f75\u305b\u3066\u5168\u4f53\u3092\u69cb\u6210\u3059\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u3063\u3066\u3001<strong>\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u95a2\u3059\u308b\u4e00\u901a\u308a\u306e\u65b9\u5411\u6027\u304c\u4e00\u65e6\u660e\u78ba\u306b\u306a\u3063\u305f<\/strong>\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7279\u306b\u3001<a href=\"https:\/\/www.fda.gov\/media\/100714\/download\" target=\"_blank\" rel=\"noopener\">\u30ac\u30a4\u30c0\u30f3\u30b9P18<\/a>\u306b\u63b2\u8f09\u306e\u3042\u308b&#8221;9.0 Pathway for Continuous Learning Leveraging Real World Performance Data&#8221;\u306e\u5185\u5bb9\u306f\u6ce8\u76ee\u3067\u3059\u3002<\/p>\n<p>\u4eba\u3005\u304c\u30c7\u30fc\u30bf\u306b\u3064\u306a\u304c\u308a\u7d9a\u3051\u308b\u3053\u3068\u3067\u3001\u84c4\u7a4d\u30fb\u66f4\u65b0\u3055\u308c\u3066\u3044\u304f\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u5bfe\u3057\u3066\u3001\u898f\u5236\u3092\u67d4\u8edf\u306b\u5bfe\u5fdc\u3055\u305b\u3066\u3044\u304f\u3053\u3068\u304c\u8003\u616e\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; 2017\u5e7412\u67088\u65e5\uff08\u91d1\uff09\u306b\u30a2\u30e1\u30ea\u30abFDA \uff08\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u3064\u3044\u3066\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u767a\u8868\u3055\u308c\u307e\u3057\u305f\u3002 &nbsp; \u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u3078\u306e\u898f\u5236\u306b\u3064\u3044\u3066\u56fd\u969b\u7684\u306a\u8db3\u4e26\u307f\u3092\u305d\u308d\u3048 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":1021,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mi_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[5],"tags":[],"_links":{"self":[{"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/posts\/1020"}],"collection":[{"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/comments?post=1020"}],"version-history":[{"count":3,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/posts\/1020\/revisions"}],"predecessor-version":[{"id":1599,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/posts\/1020\/revisions\/1599"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/media\/1021"}],"wp:attachment":[{"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/media?parent=1020"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/categories?post=1020"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/infoweb.health-life.jp\/kenko-web\/wp-json\/wp\/v2\/tags?post=1020"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}