{"id":4342,"date":"2023-08-02T10:00:59","date_gmt":"2023-08-02T02:00:59","guid":{"rendered":"https:\/\/regask.com\/?p=4342"},"modified":"2024-10-04T03:26:07","modified_gmt":"2024-10-03T19:26:07","slug":"fda-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%b7%a5%e5%85%b7%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-medical-device-tools-guidance\/","title":{"rendered":"\u7f8e\u56fdFDA\u53d1\u5e03\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d44\u683c\u4fee\u8ba2\u6307\u5357\u2026"},"content":{"rendered":"<div>\n<div>\u672c\u6700\u7ec8\u6307\u5357\u53d6\u4ee3\u4e86 2017 \u5e74 8 \u6708 10 \u65e5\u53d1\u5e03\u7684\u300a\u533b\u7597\u5668\u68b0\u5f00\u53d1\u5de5\u5177\u8d44\u683c\u8ba4\u5b9a\uff1a\u884c\u4e1a\u3001\u5de5\u5177\u5f00\u53d1\u5546\u548c\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\u5de5\u4f5c\u4eba\u5458\u6307\u5357\u300b\u3002\u8be5\u6307\u5357\u63cf\u8ff0\u4e86\u7528\u4e8e\u8bc4\u4f30 CDRH \u76d1\u7ba1\u8bbe\u5907\u7684\u533b\u7597\u5668\u68b0\u5f00\u53d1\u5de5\u5177 (MDDT) \u8d44\u683c\u8ba4\u5b9a\u7684\u81ea\u613f\u8ba1\u5212\u3002<\/div>\n<div><\/div>\n<div>\u9664\u4e86\u5173\u952e\u6982\u5ff5\u7684\u5b9a\u4e49\u548c MDDT \u8d44\u683c\u8ba1\u5212\u7684\u6982\u8ff0\u4e4b\u5916\uff0c\u8be5\u6307\u5357\u8fd8\u63d0\u4f9b\u4e86\u6709\u5173 CDRH \u8d44\u683c\u51b3\u7b56\u6846\u67b6\u548c\u8d44\u683c\u51b3\u7b56\u516c\u5f00\u4ea4\u6d41\u7684\u4fe1\u606f\u3002<\/div>\n<div><\/div>\n<div><span style=\"color: #555555;\">\u9700\u8981\u4e86\u89e3\u66f4\u591a\u6709\u5173\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u53d8\u5316\u7684\u4fe1\u606f\u5417\uff1f <\/span><a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">\u4e0e RegASK \u7684\u4e13\u5bb6\u53d6\u5f97\u8054\u7cfb\u3002<\/a><\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u66f4\u591a\u8be6\u60c5\u8bf7\u8054\u7cfb RegASK<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/zh\/%e7%b1%bb%e5%88%ab\/%e6%9c%80%e6%96%b0%e8%a7%81%e8%a7%a3\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-488769112\">\n\n\t<div id=\"col-557131346\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/zh\/%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-2\/%e8%b5%84%e6%ba%90-%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u533b\u7597\u5668\u68b0\u884c\u4e1a\u6848\u4f8b\u7814\u7a76<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>This final guidance supersedes Qualification of Medical Devices Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff issued on August 10, 2017. It describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH. In addition to definition of&#8230;<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4342","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Updates Medical Device Tools Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues revised guidance on the qualification of medical device development tools. 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Stay informed with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/fda-\u533b\u7597\u5668\u68b0\u5de5\u5177\u6307\u5357\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-02T02:00:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-03T19:26:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Issues Revised Guidance on Qualification of Medi&hellip;\",\"datePublished\":\"2023-08-02T02:00:59+00:00\",\"dateModified\":\"2024-10-03T19:26:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\"},\"wordCount\":173,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\",\"name\":\"FDA Updates Medical Device Tools Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-08-02T02:00:59+00:00\",\"dateModified\":\"2024-10-03T19:26:07+00:00\",\"description\":\"The US FDA issues revised guidance on the qualification of medical device development tools. 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