{"id":7966,"date":"2024-05-29T11:37:50","date_gmt":"2024-05-29T03:37:50","guid":{"rendered":"https:\/\/greenoo.tw\/?p=7966"},"modified":"2024-05-29T11:37:50","modified_gmt":"2024-05-29T03:37:50","slug":"%e3%80%90%e7%b6%a0%e5%9c%88%e5%9c%88%e8%aa%aa%e8%b7%a8%e5%a2%83%e3%80%91fda%e7%9b%a3%e7%ae%a1%e9%86%ab%e7%99%82%e5%99%a8%e6%a2%b0%ef%bc%9a%e7%82%ba%e6%b0%91%e7%9c%be%e5%ae%89%e5%85%a8%e8%ad%b7","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/%e3%80%90%e7%b6%a0%e5%9c%88%e5%9c%88%e8%aa%aa%e8%b7%a8%e5%a2%83%e3%80%91fda%e7%9b%a3%e7%ae%a1%e9%86%ab%e7%99%82%e5%99%a8%e6%a2%b0%ef%bc%9a%e7%82%ba%e6%b0%91%e7%9c%be%e5%ae%89%e5%85%a8%e8%ad%b7\/","title":{"rendered":"FDA's Regulation of Medical Devices: Protecting the Public's Safety"},"content":{"rendered":"<p>FDA\u76e3\u7ba1\u91ab\u7642\u5668\u68b0\uff1a\u70ba\u6c11\u773e\u5b89\u5168\u8b77\u822a<\/p>\n<p>\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u4f5c\u70ba\u5168\u7403\u516c\u8a8d\u7684\u91ab\u7642\u5668\u68b0\u76e3\u7ba1\u6a5f\u69cb\u4e4b\u4e00\uff0c\u5176\u76e3\u7ba1\u5de5\u4f5c\u5c0d\u65bc\u78ba\u4fdd\u91ab\u7642\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u81f3\u95dc\u91cd\u8981\u3002FDA\u5728\u76e3\u7ba1\u91ab\u7642\u5668\u68b0\u65b9\u9762\u64c1\u6709\u8c50\u5bcc\u7684\u7d93\u9a57\u548c\u5c08\u696d\u77e5\u8b58\uff0c\u81f4\u529b\u65bc\u4fdd\u969c\u516c\u773e\u5065\u5eb7\u548c\u5b89\u5168\u3002\u672c\u6587\u5c07\u5f9eFDA\u76e3\u7ba1\u91ab\u7642\u5668\u68b0\u7684\u89d2\u5ea6\u51fa\u767c\uff0c\u63a2\u8a0e\u5176\u5728\u7dad\u8b77\u6c11\u773e\u5b89\u5168\u65b9\u9762\u6240\u505a\u51fa\u7684\u52aa\u529b\u548c\u8ca2\u737b\u3002<\/p>\n<p>\u9996\u5148\uff0cFDA\u901a\u904e\u5236\u5b9a\u56b4\u683c\u7684\u76e3\u7ba1\u6a19\u6e96\u548c\u7a0b\u5e8f\uff0c\u78ba\u4fdd\u91ab\u7642\u5668\u68b0\u7684\u54c1\u8cea\u548c\u5b89\u5168\u6027\u7b26\u5408\u898f\u5b9a\u3002\u4efb\u4f55\u60f3\u8981\u5728\u7f8e\u570b\u5e02\u5834\u92b7\u552e\u7684\u91ab\u7642\u5668\u68b0\u90fd\u5fc5\u9808\u901a\u904eFDA\u7684\u5be9\u6279\u548c\u8a8d\u8b49\uff0c\u4e26\u63d0\u4f9b\u5145\u5206\u7684\u8b49\u64da\u8b49\u660e\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u9019\u4e00\u904e\u7a0b\u9700\u8981\u5ee0\u5546\u63d0\u4ea4\u5927\u91cf\u7684\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u548c\u76f8\u95dc\u6587\u4ef6\uff0c\u4e26\u63a5\u53d7FDA\u7684\u56b4\u683c\u5be9\u67e5\u3002\u53ea\u6709\u901a\u904e\u5be9\u6279\u7684\u91ab\u7642\u5668\u68b0\u624d\u80fd\u9032\u5165\u5e02\u5834\uff0c\u5f9e\u800c\u4fdd\u969c\u4e86\u6c11\u773e\u4f7f\u7528\u7684\u5b89\u5168\u6027\u3002<\/p>\n<p>\u5176\u6b21\uff0cFDA\u7a4d\u6975\u63a8\u52d5\u5275\u65b0\u6280\u8853\u548c\u65b0\u578b\u91ab\u7642\u5668\u68b0\u7684\u767c\u5c55\uff0c\u4ee5\u6eff\u8db3\u4e0d\u65b7\u589e\u9577\u7684\u91ab\u7642\u9700\u6c42\u3002\u901a\u904e\u8207\u91ab\u7642\u5668\u68b0\u88fd\u9020\u5546\u548c\u7814\u7a76\u6a5f\u69cb\u7684\u5408\u4f5c\uff0cFDA\u81f4\u529b\u65bc\u4fc3\u9032\u91ab\u7642\u5668\u68b0\u9818\u57df\u7684\u5275\u65b0\u548c\u767c\u5c55\u3002\u540c\u6642\uff0cFDA\u4e5f\u7a4d\u6975\u53c3\u8207\u570b\u969b\u9593\u7684\u5408\u4f5c\u548c\u4ea4\u6d41\uff0c\u5206\u4eab\u6700\u65b0\u7684\u91ab\u7642\u6280\u8853\u548c\u76e3\u7ba1\u7d93\u9a57\uff0c\u4ee5\u671f\u63a8\u52d5\u5168\u7403\u91ab\u7642\u5668\u68b0\u884c\u696d\u7684\u9032\u6b65\u548c\u767c\u5c55\u3002<\/p>\n<p>\u518d\u8005\uff0cFDA\u52a0\u5f37\u5c0d\u5e02\u5834\u4e0a\u5df2\u6709\u91ab\u7642\u5668\u68b0\u7684\u76e3\u7ba1\u548c\u76e3\u7763\uff0c\u4fdd\u969c\u6c11\u773e\u4f7f\u7528\u7684\u7522\u54c1\u5b89\u5168\u53ef\u9760\u3002\u4e00\u65e6\u767c\u73fe\u67d0\u7a2e\u91ab\u7642\u5668\u68b0\u5b58\u5728\u5b89\u5168\u96b1\u60a3\u6216\u8005\u4e0d\u826f\u53cd\u61c9\u554f\u984c\uff0cFDA\u5c07\u6703\u7acb\u5373\u4ecb\u5165\u8abf\u67e5\u4e26\u91c7\u53d6\u76f8\u61c9\u7684\u63aa\u65bd\uff0c\u5305\u62ec\u66ab\u505c\u6216\u8005\u64a4\u92b7\u7522\u54c1\u7684\u8a31\u53ef\u8b49\u3002\u9019\u7a2e\u7a4d\u6975\u7684\u76e3\u7ba1\u614b\u5ea6\u6709\u6548\u5730\u904f\u5236\u4e86\u4e0d\u5408\u683c\u7522\u54c1\u7684\u6d41\u901a\uff0c\u4fdd\u969c\u4e86\u6c11\u773e\u7684\u8eab\u9ad4\u5065\u5eb7\u548c\u5b89\u5168\u3002<\/p>\n<p>\u7e3d\u7684\u4f86\u8aaa\uff0cFDA\u5728\u76e3\u7ba1\u91ab\u7642\u5668\u68b0\u65b9\u9762\u767c\u63ee\u8457\u91cd\u8981\u7684\u4f5c\u7528\uff0c\u70ba\u6c11\u773e\u7684\u5b89\u5168\u8b77\u822a\u3002\u901a\u904e\u56b4\u683c\u7684\u76e3\u7ba1\u6a19\u6e96\u548c\u7a0b\u5e8f\u3001\u4fc3\u9032\u5275\u65b0\u6280\u8853\u548c\u65b0\u7522\u54c1\u7684\u767c\u5c55\u4ee5\u53ca\u52a0\u5f37\u5c0d\u5e02\u5834\u7684\u76e3\u7ba1\u548c\u76e3\u7763\uff0cFDA\u78ba\u4fdd\u4e86\u91ab\u7642\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u70ba\u6c11\u773e\u4f7f\u7528\u63d0\u4f9b\u4e86\u53ef\u9760\u7684\u4fdd\u969c\u3002\u76f8\u4fe1\u5728FDA\u7684\u76e3\u7ba1\u4e0b\uff0c\u91ab\u7642\u5668\u68b0\u884c\u696d\u5c07\u6703\u6301\u7e8c\u5411\u524d\u767c\u5c55\uff0c\u70ba\u6c11\u773e\u7684\u5065\u5eb7\u4fdd\u99d5\u8b77\u822a\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u76e3\u7ba1\u91ab\u7642\u5668\u68b0\uff1a\u70ba\u6c11\u773e\u5b89\u5168\u8b77\u822a \u7f8e\u570b\u98df\u54c1\u548c\u85e5\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u4f5c\u70ba\u5168\u7403\u516c\u8a8d\u7684\u91ab\u7642\u5668\u68b0\u76e3\u7ba1\u6a5f\u69cb\u4e4b\u4e00\uff0c\u5176\u76e3\u7ba1\u5de5 [&hellip;]<\/p>","protected":false},"author":11,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","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":"","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":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[45],"tags":[],"class_list":["post-7966","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/7966"}],"collection":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/comments?post=7966"}],"version-history":[{"count":0,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/7966\/revisions"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=7966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=7966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=7966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}