{"id":2587,"date":"2021-01-06T14:20:21","date_gmt":"2021-01-06T06:20:21","guid":{"rendered":"https:\/\/regask.com\/?p=2587"},"modified":"2024-10-24T01:44:27","modified_gmt":"2024-10-23T17:44:27","slug":"%e7%be%8e%e5%9b%bd-fda-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/us-fda-medical-device-guidelines\/","title":{"rendered":"\u7f8e\u56fdFDA\u63d0\u4f9b\u8981\u6c42\u6307\u5357\u5141\u8bb8\u4e09\u79cd\u2026"},"content":{"rendered":"<p>\u7f8e\u56fdFDA\u63d0\u4f9b\u4e86\u8981\u6c42\u6307\u5357\uff0c\u5141\u8bb83\u7c7b\u533b\u7597\u5668\u68b0\u8fdb\u5165\u5e02\u573a\uff0c\u4f9d\u9760\u6027\u80fd\u6807\u51c6\u6765\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n<p>\u8fd9 3 \u4e2a\u533b\u7597\u5668\u68b0\u7c7b\u522b\u5206\u522b\u662f\u810a\u67f1\u94a2\u677f\u7cfb\u7edf\u3001\u9aa8\u79d1\u975e\u810a\u67f1\u91d1\u5c5e\u9aa8\u87ba\u9489\u548c\u57ab\u5708\u3001\u4ee5\u53ca\u78c1\u5171\u632f\u63a5\u6536\u7ebf\u5708\u3002<\/p>\n<p>&nbsp;<\/p>\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\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>US FDA provided requirement guidelines to allow 3 categories of medical device into market that rely on performance criteria to demonstrate safety and effectiveness. These 3 medical device categories are spinal plating systems, orthopedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils. &nbsp;<\/p>","protected":false},"author":39,"featured_media":2486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-2587","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 v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US FDA: Medical Device Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA provides requirement guidelines for 3 categories of medical devices. 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Ensure compliance with RegASK&#039;s guidance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u7f8e\u56fd-fda-\u533b\u7597\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=\"2021-01-06T06:20:21+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-23T17:44:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/medical-device-diabetes-blood-test.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\\\/us-fda-medical-device-guidelines\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA provided requirement guidelines to allow three c&hellip;\",\"datePublished\":\"2021-01-06T06:20:21+00:00\",\"dateModified\":\"2024-10-23T17:44:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\"},\"wordCount\":90,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/\",\"name\":\"US FDA: Medical Device Guidelines | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-medical-device-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test.png\",\"datePublished\":\"2021-01-06T06:20:21+00:00\",\"dateModified\":\"2024-10-23T17:44:27+00:00\",\"description\":\"The FDA provides requirement guidelines for 3 categories of medical devices. 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