{"id":4215,"date":"2023-04-24T07:30:21","date_gmt":"2023-04-23T23:30:21","guid":{"rendered":"https:\/\/regask.com\/?p=4215"},"modified":"2024-11-22T04:50:53","modified_gmt":"2024-11-21T20:50:53","slug":"fda-%e9%aa%a8%e7%a7%91%e5%99%a8%e6%a2%b0%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-orthopedic-device-guidance\/","title":{"rendered":"\u7f8e\u56fd FDA \u62df\u8bae\u4e0a\u5e02\u524d\u63d0\u4ea4\u6307\u5357\u8349\u6848\u2026\u2026"},"content":{"rendered":"<div>\n<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09<\/a> \u63d0\u51fa\u4e86\u4e00\u4efd\u6307\u5bfc\u6587\u4ef6\u8349\u6848\uff0c\u4e3a\u7533\u8bf7\u4eba\u548c 510(k) \u4e0d\u53ef\u5438\u6536\u9aa8\u677f\u3001\u87ba\u9489\u548c\u57ab\u5708\u88c5\u7f6e\u7684\u63d0\u4ea4\u8005\u63d0\u4f9b\u5e94\u5305\u542b\u7684\u4fe1\u606f\u7684\u5efa\u8bae\u3002<\/div>\n<div><\/div>\n<div>\u8303\u56f4\u6db5\u76d6\u7528\u4e8e\u9aa8\u79d1\u9aa8\u56fa\u5b9a\u7684\u88c5\u7f6e\uff0c\u4f46\u4e0d\u5305\u62ec\u7528\u4e8e\u810a\u67f1\u3001\u4e0b\u988c\u9aa8\u3001\u988c\u9762\u3001\u9885\u9aa8\u548c\u773c\u7736\u9aa8\u6298\u56fa\u5b9a\u7684\u88c5\u7f6e\u3002<\/div>\n<div><\/div>\n<div>\u5e94\u5728 2023 \u5e74 5 \u6708 30 \u65e5\u4e4b\u524d\u63d0\u4ea4\u5bf9\u6307\u5357\u8349\u6848\u7684\u7535\u5b50\u6216\u4e66\u9762\u610f\u89c1\uff0c\u4ee5\u786e\u4fdd\u8be5\u673a\u6784\u5728\u5f00\u59cb\u5236\u5b9a\u6700\u7ec8\u7248\u672c\u4e4b\u524d\u8003\u8651\u5230\u8fd9\u4e9b\u610f\u89c1\u3002<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<div>\u9700\u8981\u4e86\u89e3\u66f4\u591a\u6709\u5173\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u53d8\u5316\u7684\u4fe1\u606f\u5417\uff1f <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><\/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:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/orthopedic-non-spinal-bone-plates-screws-and-washers-premarket-notification-510k-submissions\" 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-1332255987\">\n\n\t<div id=\"col-1940762298\" 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>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u53d1\u5e03\u4e86\u4e00\u4efd\u6307\u5bfc\u6587\u4ef6\u8349\u6848\uff0c\u5c31\u4e0d\u53ef\u5438\u6536\u9aa8\u677f\u3001\u87ba\u9489\u548c\u57ab\u5708\u7b49\u5668\u68b0\u7684 510(k) \u7533\u8bf7\u4fe1\u606f\u63d0\u4f9b\u5efa\u8bae\u3002\u8be5\u6307\u5bfc\u6587\u4ef6\u6db5\u76d6\u7528\u4e8e\u9aa8\u79d1\u9aa8\u9abc\u56fa\u5b9a\u7684\u5668\u68b0\uff0c\u4f46\u4e0d\u5305\u62ec\u7528\u4e8e\u810a\u67f1\u3001\u4e0b\u988c\u9aa8\u7b49\u90e8\u4f4d\u7684\u5668\u68b0\u3002<\/p>","protected":false},"author":39,"featured_media":3080,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4215","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 v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Draft Guidance on Orthopedic Device Submissions | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA proposes new draft guidance for premarket submissions of orthopedic non-spinal bone plates, screws, and washers. Learn more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/fda-\u9aa8\u79d1\u5668\u68b0\u6307\u5357\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Proposed Draft Guidance on Premarket Submissions for Orthopedic Non-Spinal Bone Plates, Screws, and Washers\" \/>\n<meta property=\"og:description\" content=\"The FDA proposes new draft guidance for premarket submissions of orthopedic non-spinal bone plates, screws, and washers. Learn more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/fda-\u9aa8\u79d1\u5668\u68b0\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=\"2023-04-23T23:30:21+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T20:50:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/internet-advertising-medical-devices-healthcare-computer.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-orthopedic-device-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Proposed Draft Guidance on Premarket Submissions&hellip;\",\"datePublished\":\"2023-04-23T23:30:21+00:00\",\"dateModified\":\"2024-11-21T20:50:53+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/\"},\"wordCount\":190,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/internet-advertising-medical-devices-healthcare-computer.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/\",\"name\":\"FDA Draft Guidance on Orthopedic Device Submissions | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/internet-advertising-medical-devices-healthcare-computer.png\",\"datePublished\":\"2023-04-23T23:30:21+00:00\",\"dateModified\":\"2024-11-21T20:50:53+00:00\",\"description\":\"The FDA proposes new draft guidance for premarket submissions of orthopedic non-spinal bone plates, screws, and washers. Learn more.\",\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-orthopedic-device-guidance\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/internet-advertising-medical-devices-healthcare-computer.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/internet-advertising-medical-devices-healthcare-computer.png\",\"width\":689,\"height\":626,\"caption\":\"Internet Advertising Medical Devices Healthcare Computer\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA \u5173\u4e8e\u9aa8\u79d1\u5668\u68b0\u63d0\u4ea4\u7684\u6307\u5bfc\u8349\u6848 | RegASK","description":"FDA \u63d0\u51fa\u4e86\u9488\u5bf9\u9aa8\u79d1\u975e\u810a\u67f1\u9aa8\u677f\u3001\u87ba\u9489\u548c\u57ab\u5708\u7684\u4e0a\u5e02\u524d\u63d0\u4ea4\u7684\u65b0\u6307\u5357\u8349\u6848\u3002\u4e86\u89e3\u8be6\u60c5\u3002","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/zh\/fda-\u9aa8\u79d1\u5668\u68b0\u6307\u5357\/","og_locale":"zh_CN","og_type":"article","og_title":"US FDA Proposed Draft Guidance on Premarket Submissions for Orthopedic Non-Spinal Bone Plates, Screws, and Washers","og_description":"The FDA proposes new draft guidance for premarket submissions of orthopedic non-spinal bone plates, screws, and washers. Learn more.","og_url":"https:\/\/regask.com\/zh\/fda-\u9aa8\u79d1\u5668\u68b0\u6307\u5357\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-04-23T23:30:21+00:00","article_modified_time":"2024-11-21T20:50:53+00:00","og_image":[{"width":689,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/internet-advertising-medical-devices-healthcare-computer.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"\u4f5c\u8005":"Benoit Trouwaert","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"1 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/#article","isPartOf":{"@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"US FDA Proposed Draft Guidance on Premarket Submissions&hellip;","datePublished":"2023-04-23T23:30:21+00:00","dateModified":"2024-11-21T20:50:53+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/"},"wordCount":190,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/internet-advertising-medical-devices-healthcare-computer.png","keywords":["Latest Insights"],"articleSection":["Medical Devices"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/","url":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/","name":"FDA \u5173\u4e8e\u9aa8\u79d1\u5668\u68b0\u63d0\u4ea4\u7684\u6307\u5bfc\u8349\u6848 | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/internet-advertising-medical-devices-healthcare-computer.png","datePublished":"2023-04-23T23:30:21+00:00","dateModified":"2024-11-21T20:50:53+00:00","description":"FDA \u63d0\u51fa\u4e86\u9488\u5bf9\u9aa8\u79d1\u975e\u810a\u67f1\u9aa8\u677f\u3001\u87ba\u9489\u548c\u57ab\u5708\u7684\u4e0a\u5e02\u524d\u63d0\u4ea4\u7684\u65b0\u6307\u5357\u8349\u6848\u3002\u4e86\u89e3\u8be6\u60c5\u3002","inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/fda-orthopedic-device-guidance\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/fda-orthopedic-device-guidance\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/internet-advertising-medical-devices-healthcare-computer.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/12\/internet-advertising-medical-devices-healthcare-computer.png","width":689,"height":626,"caption":"Internet Advertising Medical Devices Healthcare Computer"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"\u9762\u5411\u9ad8\u6548\u56e2\u961f\u7684\u76d1\u7ba1\u4eba\u5de5\u667a\u80fd\u64cd\u4f5c\u7cfb\u7edf","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"\u4f2f\u52aa\u74e6\u00b7\u7279\u9c81\u74e6\u7279"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/4215","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/comments?post=4215"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/4215\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media\/3080"}],"wp:attachment":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media?parent=4215"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/categories?post=4215"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/tags?post=4215"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}