{"id":430,"date":"2025-06-18T15:15:00","date_gmt":"2025-06-18T07:15:00","guid":{"rendered":"https:\/\/www.fda-registered.com\/?p=430"},"modified":"2025-08-27T15:21:09","modified_gmt":"2025-08-27T07:21:09","slug":"fda-waives-510k-registration-requirements-for-some-class-ii-clinical-electronic-thermometers","status":"publish","type":"post","link":"https:\/\/www.fda-registered.com\/en\/fda-waives-510k-registration-requirements-for-some-class-ii-clinical-electronic-thermometers\/","title":{"rendered":"FDA \u89e3\u9664\u90e8\u5206 II \u7c7b\u7535\u5b50\u4f53\u6e29\u8ba1 510(k) \u9884\u5e02\u573a\u901a\u77e5\u8981\u6c42"},"content":{"rendered":"<p><strong>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09<\/strong> \u4e8e 2025 \u5e74 6 \u6708 18 \u65e5\u6b63\u5f0f\u53d1\u5e03\u89c4\u5219\uff08Federal Register \u6587\u4ef6\u53f7 2025-11207\uff09\uff0c\u5ba3\u5e03\u5c06\u90e8\u5206 II \u7c7b <strong>\u4e34\u5e8a\u7535\u5b50\u4f53\u6e29\u8ba1\u8bbe\u5907<\/strong> 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class=\"wp-block-heading\">\u4e8c\u3001\u8c41\u514d\u5185\u5bb9\u4e0e\u9650\u5236\u8bf4\u660e<\/h4>\n\n\n\n<p>FDA \u8868\u793a\uff0c\u5bf9\u7b26\u5408 <strong>21 CFR \u00a7880.2910(b)<\/strong> \u5206\u7c7b\u7684\u7535\u5b50\u4f53\u6e29\u8ba1\u8bbe\u5907\uff0c\u82e5\u5176\u6027\u80fd\u4e0e\u5b89\u5168\u7279\u6027\u5df2\u5145\u5206\u9a8c\u8bc1\uff0c\u4e14\u80fd\u8fbe\u5230 FDA \u8ba4\u53ef\u6807\u51c6\uff0c\u53ef\u8c41\u514d\u63d0\u4ea4 510(k)\u3002\u4f46\u4ee5\u4e0b\u60c5\u51b5\u4e0d\u5728\u8c41\u514d\u8303\u56f4\u5185\uff1a\u5177\u6709\u8fdc\u7a0b\u70ed\u6210\u50cf\uff08telethermographic\uff09\u529f\u80fd\u6216\u8fde\u7eed\u6d4b\u6e29\u529f\u80fd\u7684\u8bbe\u5907\uff0c\u56e0\u5176\u53ef\u80fd\u6d89\u53ca\u65b0\u6280\u672f\u98ce\u9669\uff0c\u56e0\u6b64\u4ecd\u9700\u63d0\u4ea4 510(k)\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u4e09\u3001\u4f01\u4e1a\u5f71\u54cd\u4e0e\u884c\u4e1a\u610f\u4e49<\/h4>\n\n\n\n<p>\u6b64\u9879\u653f\u7b56\u6709\u52a9\u4e8e\u4f01\u4e1a\u51cf\u5c11\u5408\u89c4\u6210\u672c\u548c\u7533\u8bf7\u65f6\u95f4\uff0c\u52a0\u901f\u8fdb\u5165\u5e02\u573a\uff0c\u540c\u65f6 FDA \u80fd\u5c06\u8d44\u6e90\u96c6\u4e2d\u5728\u9ad8\u98ce\u9669\u8bbe\u5907\u76d1\u7ba1\u4e0a\uff0c\u5b9e\u73b0\u76d1\u7ba1\u6548\u7387\u4e0e\u5b89\u5168\u4fdd\u969c\u7684\u5e73\u8861\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u4f01\u4e1a\u5408\u89c4\u5efa\u8bae<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8bc4\u4f30\u4ea7\u54c1\u662f\u5426\u7b26\u5408\u8c41\u514d\u6761\u4ef6<\/strong>\uff1a\u4ea7\u54c1\u5e94\u7b26\u5408\u6027\u80fd\u6807\u51c6\u5e76\u4e0d\u5b58\u5728\u65b0\u6280\u672f\u98ce\u9669\uff1b\u82e5\u5177\u5907\u8fdc\u7a0b\u6216\u8fde\u7eed\u6d4b\u6e29\u529f\u80fd\uff0c\u4ecd\u9700\u63d0\u4ea4 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\u9884\u5e02\u573a\u901a\u77e5\u8981\u6c42\u4e2d\u8c41\u514d\uff0c\u4ee5\u964d\u4f4e\u76d1\u7ba1\u8d1f\u62c5\u3001\u51cf\u5c11\u4f01\u4e1a\u6210\u672c\uff0c\u5e76\u63a8\u52a8\u8fd9\u7c7b\u4f4e\u98ce\u9669\u8bbe\u5907\u66f4\u5feb\u8fdb\u5165\u5e02\u573a\u3002<\/p>","protected":false},"author":1,"featured_media":431,"comment_status":"open","ping_status":"open","sticky":false,"template":"template-single-sidebar","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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