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decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/vcro.online\/cn\/wp-content\/uploads\/2024\/07\/c32d851e-4184-4eea-b9e2-a308abf66288.jpg\" alt=\"\" class=\"wp-image-1642\" srcset=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/c32d851e-4184-4eea-b9e2-a308abf66288.jpg 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/c32d851e-4184-4eea-b9e2-a308abf66288-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/c32d851e-4184-4eea-b9e2-a308abf66288-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/c32d851e-4184-4eea-b9e2-a308abf66288-768x768.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>\u5ef6\u4f38\u9605\u8bfb:<br>1. U.S. FDA. Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions Guidance for Industry and Food and Drug Administration Staff, February 2018.<br>2. U.S. FDA. Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies, January 2006.<br>3. 21 CFR Part 812<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e8e2018\u5e742\u670821\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u4fee\u8ba2\u4e86\u5176\u5bf9\u4e8e\u533b\u7597\u5668\u6750\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u63a5\u53d7\u89c4\u5b9a\uff0c\u5e2e\u52a9\u7533\u8bf7\u4eba [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1493","post","type-post","status-publish","format-standard","hentry","category-7"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>FDA \u5bf9\u533b\u7597\u5668\u6750\u5728\u7f8e\u56fd\u5883\u5916\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u67e5\u5efa\u8bae - 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