{"id":19210,"date":"2026-01-02T16:22:32","date_gmt":"2026-01-02T08:22:32","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19210"},"modified":"2026-01-02T16:22:32","modified_gmt":"2026-01-02T08:22:32","slug":"fda-medical-device-pathways-510k-de-novo-pma-comparison-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/fda-medical-device-pathways-510k-de-novo-pma-comparison-2026\/","title":{"rendered":"FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u5168\u89e3\u6790\uff1a510(k)\u3001De Novo\u3001PMA \u600e\u9ebc\u9078\uff1f\uff082026 \u6700\u65b0\uff09"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h2>\u9078\u5c0d\u8def\u5f91\u662f\u6210\u529f\u95dc\u9375\uff1a\u4e09\u5927\u9014\u5f91\u9069\u7528\u60c5\u5883\u4e00\u6b21\u770b\u61c2<\/h2>\n<p>FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u9078\u64c7\u53d6\u6c7a\u65bc\u300c\u7522\u54c1\u98a8\u96aa\u5206\u985e\u300d\u8207\u300c\u662f\u5426\u6709\u540c\u985e\u7522\u54c1\uff08Predicate Device\uff09\u300d\u3002\u6839\u64da 21 CFR Part 807 \u8207 21 CFR Part 814 \u898f\u5b9a\uff0c\u4e3b\u8981\u6709\u4e09\u5927\u5be9\u67e5\u9014\u5f91\uff1a<\/p>\n<ol>\n<li><strong>510(k) Premarket Notification<\/strong>\uff1a\u9069\u7528\u65bc Class II \u6216\u90e8\u5206 Class I \u5668\u68b0\uff0c\u9700\u8b49\u660e\u8207\u5df2\u6838\u51c6\u7522\u54c1\u300c\u5be6\u8cea\u7b49\u6548\u300d\uff08Substantially Equivalent\uff09<\/li>\n<li><strong>De Novo Classification<\/strong>\uff1a\u9069\u7528\u65bc\u4f4e\u81f3\u4e2d\u98a8\u96aa\u4f46\u7121 Predicate Device \u7684\u5275\u65b0\u5668\u68b0\uff0c\u53ef\u5efa\u7acb\u65b0\u7522\u54c1\u5206\u985e<\/li>\n<li><strong>PMA (Premarket Approval)<\/strong>\uff1a\u9069\u7528\u65bc Class III \u9ad8\u98a8\u96aa\u5668\u68b0\uff0c\u9700\u63d0\u4f9b\u5b8c\u6574\u81e8\u5e8a\u6578\u64da\u8b49\u660e\u5b89\u5168\u6027\u8207\u6709\u6548\u6027<\/li>\n<\/ol>\n<p>\u9078\u932f\u8def\u5f91\u7684\u4ee3\u50f9\uff1a<img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19211\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-510k-de-novo-pma-comparison-feature-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u5168\u89e3\u6790\u5c01\u9762\uff0c\u986f\u793a 510(k)\u3001De Novo\u3001PMA \u4e09\u5927\u5be9\u67e5\u9014\u5f91\u9078\u64c7\u8207 2026 \u6700\u65b0\u7b56\u7565\" width=\"2848\" height=\"1504\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-510k-de-novo-pma-comparison-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-510k-de-novo-pma-comparison-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-510k-de-novo-pma-comparison-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-510k-de-novo-pma-comparison-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-510k-de-novo-pma-comparison-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2848px) 100vw, 2848px\" \/>\u82e5\u9078\u64c7 510(k) \u4f46 FDA \u5224\u5b9a\u9700 PMA\uff0c\u9700\u91cd\u65b0\u7533\u8acb\u4e26\u88dc\u5145\u81e8\u5e8a\u6578\u64da\uff0c\u53ef\u80fd\u5ef6\u8aa4 1-3 \u5e74\u4e0a\u5e02\u6642\u7a0b\u3002\u53cd\u4e4b\uff0c\u82e5\u53ef\u8d70 510(k) \u537b\u9078\u64c7 PMA\uff0c\u5c07\u5927\u5e45\u589e\u52a0\u6210\u672c\uff08PMA \u8cbb\u7528\u7d04 510(k) \u7684 10-20 \u500d\uff09\u8207\u5be9\u67e5\u6642\u9593\u3002<\/p>\n<hr \/>\n<h2>FDA \u4e09\u5927\u5be9\u67e5\u9014\u5f91\u5b8c\u6574\u6bd4\u8f03<\/h2>\n<h3>\u6838\u5fc3\u5dee\u7570\u7e3d\u89bd\u8868<\/h3>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>\u6bd4\u8f03\u9805\u76ee<\/th>\n<th>510(k)<\/th>\n<th>De Novo<\/th>\n<th>PMA<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u9069\u7528\u5206\u985e<\/strong><\/td>\n<td>Class II\uff08\u90e8\u5206 Class I\uff09<\/td>\n<td>Class I\/II\uff08\u7121 Predicate\uff09<\/td>\n<td>Class III<\/td>\n<\/tr>\n<tr>\n<td><strong>Core requirements<\/strong><\/td>\n<td>\u8b49\u660e Substantial Equivalence<\/td>\n<td>\u8b49\u660e\u4f4e\u81f3\u4e2d\u98a8\u96aa + \u7121 Predicate<\/td>\n<td>\u5b8c\u6574\u81e8\u5e8a\u6578\u64da + \u5b89\u5168\u6709\u6548\u6027<\/td>\n<\/tr>\n<tr>\n<td><strong>Review Time<\/strong><\/td>\n<td>90 \u5929\uff08FDA \u76ee\u6a19\uff0c\u5be6\u969b 3-6 \u500b\u6708\uff09<\/td>\n<td>150 \u5929\uff08FDA \u76ee\u6a19\uff0c\u5be6\u969b 6-12 \u500b\u6708\uff09<\/td>\n<td>180 \u5929\uff08FDA \u76ee\u6a19\uff0c\u5be6\u969b 1-3 \u5e74\uff09<\/td>\n<\/tr>\n<tr>\n<td><strong>\u7533\u8acb\u8cbb\u7528<\/strong><\/td>\n<td>$13,000-$20,000\uff082026 MDUFA\uff09<\/td>\n<td>$122,000-$150,000<\/td>\n<td>$400,000-$500,000+<\/td>\n<\/tr>\n<tr>\n<td><strong>\u81e8\u5e8a\u6578\u64da<\/strong><\/td>\n<td>\u901a\u5e38\u4e0d\u9700\u8981\uff08\u9664\u975e FDA \u8981\u6c42\uff09<\/td>\n<td>\u53ef\u80fd\u9700\u8981\uff08\u8996\u98a8\u96aa\u800c\u5b9a\uff09<\/td>\n<td>Must provide<\/td>\n<\/tr>\n<tr>\n<td><strong>\u6838\u51c6\u5f8c\u76e3\u7ba1<\/strong><\/td>\n<td>Post-Market Surveillance<\/td>\n<td>Post-Market Surveillance<\/td>\n<td>\u56b4\u683c Post-Approval Study<\/td>\n<\/tr>\n<tr>\n<td><strong>success rate<\/strong><\/td>\n<td>\u7d04 85-90%<\/td>\n<td>\u7d04 75-80%<\/td>\n<td>\u7d04 50-60%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>\u26a0\ufe0f <strong>important reminder<\/strong>\uff1a\u8cbb\u7528\u70ba 2026 \u5e74 MDUFA V \u6a19\u6e96\uff0c\u5be6\u969b\u8cbb\u7528\u8996\u516c\u53f8\u898f\u6a21\uff08Small Business \u53ef\u6e1b\u514d\uff09\u8207\u7522\u54c1\u8907\u96dc\u5ea6\u800c\u7570\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u9078\u64c7\u6c7a\u7b56\u6a39<\/h3>\n<p><strong>Description of the use of the picture<\/strong>:<br \/>\n\u6b64\u6c7a\u7b56\u6a39\u5c07\u300c510(k) vs De Novo vs PMA\u300d\u7684\u9078\u64c7\u908f\u8f2f\u8996\u89ba\u5316\uff0c\u5e6b\u52a9\u53f0\u7063\u91ab\u6750\u5ee0\u5feb\u901f\u5224\u5b9a\u9069\u5408\u7684\u5be9\u67e5\u9014\u5f91\u3002<\/p>\n<div class=\"MarkdownCodeBlock_container__nRn2j\">\n<div class=\"MarkdownCodeBlock_codeBlock__rvLec force-dark\">\n<div class=\"MarkdownCodeBlock_codeFooterPoePython__8QxYT\">\n<div class=\"MarkdownCodeBlock_codeFooterRightSection__9Hz_z\"><img decoding=\"async\" class=\"alignnone size-full wp-image-19212\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathway-selection-decision-tree-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u9078\u64c7\u6c7a\u7b56\u6a39\uff0c\u986f\u793a\u5f9e\u7522\u54c1\u5206\u985e\u5230 510(k)\u3001De Novo\u3001PMA \u9014\u5f91\u5224\u5b9a\u7684\u5b8c\u6574\u6d41\u7a0b\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathway-selection-decision-tree-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathway-selection-decision-tree-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathway-selection-decision-tree-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathway-selection-decision-tree-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathway-selection-decision-tree-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/div>\n<\/div>\n<\/div>\n<\/div>\n<hr \/>\n<h2>510(k) \u9014\u5f91\uff1a\u6700\u5e38\u898b\u4f46\u9700\u627e\u5230 Predicate Device<\/h2>\n<h3>\u9069\u7528\u689d\u4ef6\u8207\u6838\u5fc3\u8981\u6c42<\/h3>\n<p><strong>Applicable Products<\/strong>::<\/p>\n<ul>\n<li>Class II \u91ab\u7642\u5668\u68b0\uff08\u7d04\u5360\u6240\u6709\u5668\u68b0\u7684 43%\uff09<\/li>\n<li>\u90e8\u5206 Class I \u5668\u68b0\uff08\u82e5\u672a\u8c41\u514d 510(k)\uff09<\/li>\n<li>\u9700\u8207\u5df2\u6838\u51c6\u7684 Predicate Device \u5177\u300c\u5be6\u8cea\u7b49\u6548\u6027\u300d\uff08Substantial Equivalence\uff09<\/li>\n<\/ul>\n<p><strong>Substantial Equivalence \u5224\u5b9a\u6a19\u6e96<\/strong>::<\/p>\n<ol>\n<li><strong>Intended Use \u76f8\u540c\u6216\u76f8\u4f3c<\/strong>\uff1a\u9810\u671f\u7528\u9014\u5fc5\u9808\u4e00\u81f4<\/li>\n<li><strong>\u6280\u8853\u7279\u6027\u76f8\u540c<\/strong>\uff1a\u6750\u6599\u3001\u8a2d\u8a08\u3001\u80fd\u6e90\u4f86\u6e90\u3001\u64cd\u4f5c\u539f\u7406\u7b49<\/li>\n<li><strong>\u6027\u80fd\u6578\u64da\u76f8\u7576<\/strong>\uff1a\u82e5\u6280\u8853\u7279\u6027\u4e0d\u540c\uff0c\u9700\u8b49\u660e\u6027\u80fd\u4e0d\u52a3\u65bc Predicate Device<\/li>\n<\/ol>\n<p><strong>\u7533\u8acb\u6d41\u7a0b<\/strong>::<\/p>\n<ol>\n<li>\u78ba\u8a8d\u7522\u54c1\u5206\u985e\uff08\u4f7f\u7528 FDA Product Classification Database\uff09<\/li>\n<li>\u5c0b\u627e Predicate Device\uff08\u4f7f\u7528 FDA 510(k) Database\uff09<\/li>\n<li>\u6e96\u5099 510(k) \u7533\u8acb\u6587\u4ef6\uff08\u5305\u542b Substantial Equivalence \u6bd4\u8f03\u3001\u6027\u80fd\u6e2c\u8a66\u6578\u64da\uff09<\/li>\n<li>\u63d0\u4ea4\u81f3 FDA\uff08\u96fb\u5b50\u63d0\u4ea4\u7cfb\u7d71 eSTAR\uff09<\/li>\n<li>FDA \u5be9\u67e5\uff0890 \u5929\u76ee\u6a19\uff0c\u53ef\u80fd\u8981\u6c42\u88dc\u4ef6\uff09<\/li>\n<li>\u7372\u5f97 510(k) Clearance<\/li>\n<\/ol>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>\uff1a\u9078\u64c7 Predicate Device \u6642\uff0c\u512a\u5148\u9078\u64c7\u300c\u8fd1\u671f\u6838\u51c6\u300d\uff085 \u5e74\u5167\uff09\u4e14\u300c\u6280\u8853\u7279\u6027\u9ad8\u5ea6\u76f8\u4f3c\u300d\u7684\u7522\u54c1\uff0c\u53ef\u964d\u4f4e FDA \u8981\u6c42\u984d\u5916\u6578\u64da\u7684\u98a8\u96aa\u3002<\/p>\n<h3>\u5e38\u898b\u9000\u4ef6\u539f\u56e0\u8207\u907f\u5751\u6307\u5357<\/h3>\n<p><strong>\u9000\u4ef6\u539f\u56e0 Top 3<\/strong>::<\/p>\n<ol>\n<li><strong>Predicate Device \u9078\u64c7\u4e0d\u7576<\/strong>\uff1aIntended Use \u4e0d\u4e00\u81f4\u6216\u6280\u8853\u5dee\u7570\u904e\u5927<\/li>\n<li><strong>\u6027\u80fd\u6e2c\u8a66\u6578\u64da\u4e0d\u8db3<\/strong>\uff1a\u672a\u63d0\u4f9b\u8db3\u5920\u7684 Bench Testing \u6216 Biocompatibility \u6578\u64da<\/li>\n<li><strong>\u6a19\u7c64\u8cc7\u8a0a\u4e0d\u5b8c\u6574<\/strong>\uff1a\u672a\u7b26\u5408 21 CFR Part 801 \u8981\u6c42<\/li>\n<\/ol>\n<p><strong>\u907f\u5751\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u63d0\u4ea4\u524d\u9032\u884c Pre-Submission Meeting\uff08\u8207 FDA \u8a0e\u8ad6 Predicate Device \u9078\u64c7\uff09<\/li>\n<li>\u59d4\u8a17\u7b2c\u4e09\u65b9\u5be6\u9a57\u5ba4\u9032\u884c\u6027\u80fd\u6e2c\u8a66\uff08\u78ba\u4fdd\u6578\u64da\u53ef\u4fe1\u5ea6\uff09<\/li>\n<li>\u53c3\u8003 FDA Guidance Documents\uff08\u5982 &#8220;The 510(k) Program: Evaluating Substantial Equivalence&#8221;\uff09<\/li>\n<\/ul>\n<hr \/>\n<h2>De Novo \u9014\u5f91\uff1a\u5275\u65b0\u5668\u68b0\u7684\u65b0\u9078\u64c7<\/h2>\n<h3>\u9069\u7528\u689d\u4ef6\u8207\u6838\u5fc3\u512a\u52e2<\/h3>\n<p><strong>Applicable Products<\/strong>::<\/p>\n<ul>\n<li>\u4f4e\u81f3\u4e2d\u98a8\u96aa\u5668\u68b0\uff08Class I \u6216 Class II\uff09<\/li>\n<li><strong>\u7121 Predicate Device \u53ef\u4f9b\u6bd4\u8f03<\/strong>\uff08\u5168\u65b0\u985e\u578b\u7522\u54c1\uff09<\/li>\n<li>\u53ef\u8b49\u660e\u7522\u54c1\u98a8\u96aa\u53ef\u900f\u904e General Controls \u6216 Special Controls \u7ba1\u7406<\/li>\n<\/ul>\n<p><strong>\u6838\u5fc3\u512a\u52e2<\/strong>::<\/p>\n<ol>\n<li><strong>\u5efa\u7acb\u65b0\u7522\u54c1\u5206\u985e<\/strong>\uff1a\u6210\u529f\u5f8c\u53ef\u6210\u70ba\u5176\u4ed6\u5ee0\u5546\u7684 Predicate Device<\/li>\n<li><strong>\u907f\u514d PMA \u9ad8\u6210\u672c<\/strong>\uff1a\u76f8\u8f03 PMA \u7bc0\u7701 60-80% \u8cbb\u7528\u8207\u6642\u9593<\/li>\n<li><strong>\u5e02\u5834\u5148\u6a5f<\/strong>\uff1a\u6210\u70ba\u8a72\u985e\u7522\u54c1\u7684\u300cFirst in Class\u300d<\/li>\n<\/ol>\n<p><strong>\u7533\u8acb\u6d41\u7a0b<\/strong>::<\/p>\n<ol>\n<li>\u78ba\u8a8d\u7522\u54c1\u7121 Predicate Device\uff08\u67e5\u8a62 FDA 510(k) Database\uff09<\/li>\n<li>\u8a55\u4f30\u7522\u54c1\u98a8\u96aa\u7b49\u7d1a\uff08\u662f\u5426\u53ef\u900f\u904e General\/Special Controls \u7ba1\u7406\uff09<\/li>\n<li>\u6e96\u5099 De Novo \u7533\u8acb\u6587\u4ef6\uff08\u5305\u542b\u98a8\u96aa\u5206\u6790\u3001\u6027\u80fd\u6578\u64da\u3001\u5efa\u8b70 Controls\uff09<\/li>\n<li>\u63d0\u4ea4\u81f3 FDA\uff08\u96fb\u5b50\u63d0\u4ea4\u7cfb\u7d71\uff09<\/li>\n<li>FDA \u5be9\u67e5\uff08150 \u5929\u76ee\u6a19\uff0c\u53ef\u80fd\u8981\u6c42\u88dc\u4ef6\u6216\u81e8\u5e8a\u6578\u64da\uff09<\/li>\n<li>\u7372\u5f97 De Novo Authorization \u8207\u65b0\u7522\u54c1\u5206\u985e<\/li>\n<\/ol>\n<p>\u26a0\ufe0f <strong>important reminder<\/strong>\uff1aDe Novo \u6210\u529f\u7387\u7d04 75-80%\uff0c\u82e5\u88ab\u62d2\u7d55\uff0c\u53ef\u80fd\u9700\u6539\u8d70 PMA \u9014\u5f91\u6216\u91cd\u65b0\u8a2d\u8a08\u7522\u54c1\u964d\u4f4e\u98a8\u96aa\u3002<\/p>\n<h3>\u5178\u578b\u6210\u529f\u6848\u4f8b<\/h3>\n<p><strong>\u6848\u4f8b\u4e00\uff1a\u667a\u6167\u624b\u74b0\u5fc3\u7387\u76e3\u6e2c\u529f\u80fd<\/strong><\/p>\n<ul>\n<li>\u7522\u54c1\uff1a\u5177\u5fc3\u7387\u76e3\u6e2c\u529f\u80fd\u7684\u667a\u6167\u624b\u74b0<\/li>\n<li>\u6311\u6230\uff1a\u7121 Predicate Device\uff08\u7576\u6642\u667a\u6167\u624b\u74b0\u5c1a\u672a\u88ab\u5206\u985e\u70ba\u91ab\u7642\u5668\u68b0\uff09<\/li>\n<li>\u89e3\u6c7a\u65b9\u6848\uff1a\u900f\u904e De Novo \u5efa\u7acb\u65b0\u5206\u985e\uff08Class II, Special Controls\uff09<\/li>\n<li>\u7d50\u679c\uff1a\u6210\u70ba\u5f8c\u7e8c\u540c\u985e\u7522\u54c1\u7684 Predicate Device<\/li>\n<\/ul>\n<p><strong>\u6848\u4f8b\u4e8c\uff1aAI \u8f14\u52a9\u8a3a\u65b7\u8edf\u9ad4<\/strong><\/p>\n<ul>\n<li>\u7522\u54c1\uff1aAI \u5f71\u50cf\u8fa8\u8b58\u8f14\u52a9\u8a3a\u65b7\u8edf\u9ad4<\/li>\n<li>\u6311\u6230\uff1aAI \u6f14\u7b97\u6cd5\u7121\u50b3\u7d71 Predicate Device<\/li>\n<li>\u89e3\u6c7a\u65b9\u6848\uff1aDe Novo \u7533\u8acb\uff0c\u63d0\u4f9b\u6f14\u7b97\u6cd5\u9a57\u8b49\u6578\u64da\u8207\u81e8\u5e8a\u6027\u80fd\u8a55\u4f30<\/li>\n<li>\u7d50\u679c\uff1a\u5efa\u7acb AI \u91ab\u7642\u8edf\u9ad4\u65b0\u5206\u985e<\/li>\n<\/ul>\n<hr \/>\n<h2>PMA \u9014\u5f91\uff1a\u9ad8\u98a8\u96aa\u5668\u68b0\u7684\u56b4\u683c\u5be9\u67e5<\/h2>\n<h3>\u9069\u7528\u689d\u4ef6\u8207\u6311\u6230<\/h3>\n<p><strong>Applicable Products<\/strong>::<\/p>\n<ul>\n<li>Class III \u9ad8\u98a8\u96aa\u5668\u68b0\uff08\u5982\u5fc3\u81df\u652f\u67b6\u3001\u4eba\u5de5\u5fc3\u81df\u74e3\u819c\u3001\u690d\u5165\u5f0f\u9664\u986b\u5668\uff09<\/li>\n<li>\u76f4\u63a5\u7dad\u6301\u751f\u547d\u6216\u9810\u9632\u56b4\u91cd\u5065\u5eb7\u640d\u5bb3\u7684\u5668\u68b0<\/li>\n<li>\u9700\u63d0\u4f9b\u5b8c\u6574\u81e8\u5e8a\u6578\u64da\u8b49\u660e\u300c\u5408\u7406\u4fdd\u8b49\u5b89\u5168\u6027\u8207\u6709\u6548\u6027\u300d\uff08Reasonable Assurance of Safety and Effectiveness\uff09<\/li>\n<\/ul>\n<p><strong>\u6838\u5fc3\u6311\u6230<\/strong>::<\/p>\n<ol>\n<li><strong>\u81e8\u5e8a\u8a66\u9a57\u6210\u672c\u9ad8<\/strong>\uff1a\u9700\u9032\u884c IDE\uff08Investigational Device Exemption\uff09\u81e8\u5e8a\u8a66\u9a57\uff0c\u6210\u672c\u53ef\u9054\u6578\u767e\u842c\u7f8e\u5143<\/li>\n<li><strong>\u5be9\u67e5\u6642\u9593\u9577<\/strong>\uff1a\u5e73\u5747 1-3 \u5e74\uff08\u542b\u88dc\u4ef6\u8207\u81e8\u5e8a\u6578\u64da\u5be9\u67e5\uff09<\/li>\n<li><strong>\u6210\u529f\u7387\u8f03\u4f4e<\/strong>\uff1a\u7d04 50-60%\uff08\u56b4\u683c\u7684\u5b89\u5168\u6027\u8207\u6709\u6548\u6027\u6a19\u6e96\uff09<\/li>\n<\/ol>\n<p><strong>\u7533\u8acb\u6d41\u7a0b<\/strong>::<\/p>\n<ol>\n<li>\u9032\u884c\u81e8\u5e8a\u524d\u6e2c\u8a66\uff08Bench Testing, Animal Studies\uff09<\/li>\n<li>\u7533\u8acb IDE\uff08\u82e5\u9700\u9032\u884c\u81e8\u5e8a\u8a66\u9a57\uff09<\/li>\n<li>\u5b8c\u6210\u81e8\u5e8a\u8a66\u9a57\uff08\u9700\u7b26\u5408 GCP \u8207 21 CFR Part 812\uff09<\/li>\n<li>\u6e96\u5099 PMA \u7533\u8acb\u6587\u4ef6\uff08\u5305\u542b\u5b8c\u6574\u81e8\u5e8a\u6578\u64da\u3001\u88fd\u9020\u8cc7\u8a0a\u3001\u6a19\u7c64\uff09<\/li>\n<li>\u63d0\u4ea4\u81f3 FDA\uff08\u96fb\u5b50\u63d0\u4ea4\u7cfb\u7d71\uff09<\/li>\n<li>FDA \u5be9\u67e5\uff08\u53ef\u80fd\u53ec\u958b Advisory Committee Meeting\uff09<\/li>\n<li>\u7372\u5f97 PMA Approval<\/li>\n<\/ol>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>\uff1aPMA \u7533\u8acb\u524d\u5efa\u8b70\u9032\u884c\u591a\u6b21 Pre-Submission Meeting\uff0c\u8207 FDA \u78ba\u8a8d\u81e8\u5e8a\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7d42\u9ede\uff08Primary Endpoint\uff09\u8207\u7d71\u8a08\u5206\u6790\u8a08\u756b\uff0c\u53ef\u964d\u4f4e\u5f8c\u7e8c\u88dc\u4ef6\u98a8\u96aa\u3002<\/p>\n<hr \/>\n<h3>\u5716 3: FDA \u4e09\u5927\u5be9\u67e5\u9014\u5f91\u6210\u672c\u8207\u6642\u9593\u6bd4\u8f03<\/h3>\n<p><strong>Description of the use of the picture<\/strong>:<br \/>\n\u6b64\u6bd4\u8f03\u5716\u6574\u7406 510(k)\u3001De Novo\u3001PMA \u4e09\u5927\u9014\u5f91\u7684\u6210\u672c\u8207\u5be9\u67e5\u6642\u9593\u5dee\u7570\uff0c\u5e6b\u52a9\u696d\u8005\u8a55\u4f30\u8cc7\u6e90\u6295\u5165\u8207\u4e0a\u5e02\u6642\u7a0b\u898f\u5283\u3002<\/p>\n<div class=\"MarkdownCodeBlock_container__nRn2j\">\n<div class=\"MarkdownCodeBlock_codeBlock__rvLec force-dark\">\n<div class=\"MarkdownCodeBlock_codeFooterPoePython__8QxYT\">\n<div class=\"MarkdownCodeBlock_codeFooterRightSection__9Hz_z\"><img decoding=\"async\" class=\"alignnone size-full wp-image-19213\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-cost-time-comparison-chart-2026.png\" alt=\"FDA \u4e09\u5927\u5be9\u67e5\u9014\u5f91\u6210\u672c\u8207\u6642\u9593\u6bd4\u8f03\u5716\uff0c\u986f\u793a 510(k)\u3001De Novo\u3001PMA \u7684\u7533\u8acb\u8cbb\u7528\u8207\u5be9\u67e5\u6642\u9593\u5dee\u7570\uff082026 \u6a19\u6e96\uff09\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-cost-time-comparison-chart-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-cost-time-comparison-chart-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-cost-time-comparison-chart-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-cost-time-comparison-chart-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-pathways-cost-time-comparison-chart-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<hr \/>\n<h2>\u5982\u4f55\u9078\u64c7\u6700\u9069\u5408\u7684\u5be9\u67e5\u9014\u5f91\uff1f<\/h2>\n<h3>\u9078\u64c7\u7b56\u7565\u6c7a\u7b56\u6846\u67b6<\/h3>\n<p><strong>\u6b65\u9a5f\u4e00\uff1a\u78ba\u8a8d\u7522\u54c1\u98a8\u96aa\u5206\u985e<\/strong><\/p>\n<ul>\n<li>\u4f7f\u7528 FDA Product Classification Database \u67e5\u8a62<\/li>\n<li>\u53c3\u8003 21 CFR Part 862-892 \u7522\u54c1\u5206\u985e\u898f\u5b9a<\/li>\n<li>\u82e5\u7121\u660e\u78ba\u5206\u985e\uff0c\u53ef\u63d0\u4ea4 513(g) Request\uff08\u5206\u985e\u5224\u5b9a\u8acb\u6c42\uff09<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f\u4e8c\uff1a\u8a55\u4f30 Predicate Device \u53ef\u5f97\u6027<\/strong><\/p>\n<ul>\n<li>\u641c\u5c0b FDA 510(k) Database\uff08\u81f3\u5c11\u627e 2-3 \u500b\u5019\u9078\uff09<\/li>\n<li>\u6bd4\u8f03 Intended Use\u3001\u6280\u8853\u7279\u6027\u3001\u6027\u80fd\u53c3\u6578<\/li>\n<li>\u82e5\u7121\u5408\u9069 Predicate\uff0c\u8003\u616e De Novo \u6216 PMA<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f\u4e09\uff1a\u8a55\u4f30\u8cc7\u6e90\u8207\u6642\u7a0b<\/strong><\/p>\n<ul>\n<li><strong>510(k)<\/strong>\uff1a\u9069\u5408\u8cc7\u6e90\u6709\u9650\u3001\u9700\u5feb\u901f\u4e0a\u5e02\u7684 Class II \u7522\u54c1<\/li>\n<li><strong>De Novo<\/strong>\uff1a\u9069\u5408\u5275\u65b0\u7522\u54c1\u3001\u9858\u610f\u6295\u5165\u4e2d\u7b49\u8cc7\u6e90\u5efa\u7acb\u65b0\u5206\u985e<\/li>\n<li><strong>PMA<\/strong>\uff1a\u9069\u5408 Class III \u7522\u54c1\u3001\u6709\u5145\u8db3\u8cc7\u6e90\u9032\u884c\u81e8\u5e8a\u8a66\u9a57<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f\u56db\uff1a\u8003\u91cf\u9577\u671f\u7b56\u7565<\/strong><\/p>\n<ul>\n<li><strong>510(k)<\/strong>\uff1a\u4e0a\u5e02\u5feb\u4f46\u7121\u5c08\u5c6c\u6027\uff08\u7af6\u722d\u8005\u53ef\u7528\u4f60\u7684\u7522\u54c1\u4f5c Predicate\uff09<\/li>\n<li><strong>De Novo<\/strong>\uff1a\u53ef\u5efa\u7acb\u5e02\u5834\u5148\u6a5f\uff0c\u6210\u70ba Predicate Device<\/li>\n<li><strong>PMA<\/strong>\uff1a\u6838\u51c6\u5f8c\u5177\u9ad8\u9032\u5165\u9580\u6abb\uff0c\u7af6\u722d\u8005\u96e3\u4ee5\u8907\u88fd<\/li>\n<\/ul>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 3 \u500b\u9078\u64c7\u9677\u9631<\/h2>\n<h3>\u9677\u9631\u4e00\uff1a\u8aa4\u5224\u7522\u54c1\u98a8\u96aa\u5206\u985e<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u81ea\u884c\u5224\u5b9a\u70ba Class II \u4e26\u6e96\u5099 510(k)\uff0c\u4f46 FDA \u5be9\u67e5\u5f8c\u8981\u6c42\u6539\u8d70 PMA\uff0c\u5c0e\u81f4\u91cd\u65b0\u7533\u8acb\u8207\u88dc\u5145\u81e8\u5e8a\u6578\u64da\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u63d0\u4ea4\u524d\u9032\u884c 513(g) Request\uff08\u5206\u985e\u5224\u5b9a\u8acb\u6c42\uff09<\/li>\n<li>\u53c3\u52a0 Pre-Submission Meeting \u8207 FDA \u78ba\u8a8d\u5206\u985e<\/li>\n<li>\u53c3\u8003\u540c\u985e\u7522\u54c1\u7684\u6838\u51c6\u6b77\u53f2<\/li>\n<\/ul>\n<h3>\u9677\u9631\u4e8c\uff1a\u9078\u64c7\u4e0d\u7576\u7684 Predicate Device<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u9078\u64c7\u7684 Predicate Device \u8207\u65b0\u7522\u54c1 Intended Use \u6216\u6280\u8853\u7279\u6027\u5dee\u7570\u904e\u5927\uff0c\u5c0e\u81f4 510(k) \u88ab\u62d2\u7d55\u6216\u8981\u6c42\u88dc\u5145\u5927\u91cf\u6578\u64da\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u9078\u64c7\u300c\u8fd1\u671f\u6838\u51c6\u300d\uff085 \u5e74\u5167\uff09\u7684 Predicate<\/li>\n<li>\u512a\u5148\u9078\u64c7\u300c\u6280\u8853\u7279\u6027\u9ad8\u5ea6\u76f8\u4f3c\u300d\u7684\u7522\u54c1<\/li>\n<li>\u6e96\u5099\u591a\u500b\u5099\u9078 Predicate\uff08\u81f3\u5c11 2-3 \u500b\uff09<\/li>\n<\/ul>\n<h3>\u9677\u9631\u4e09\uff1a\u4f4e\u4f30 De Novo \u6216 PMA \u7684\u6642\u9593\u8207\u6210\u672c<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u672a\u5145\u5206\u8a55\u4f30 De Novo \u6216 PMA \u7684\u8cc7\u6e90\u9700\u6c42\uff0c\u5c0e\u81f4\u7533\u8acb\u904e\u7a0b\u4e2d\u8cc7\u91d1\u6216\u6642\u9593\u4e0d\u8db3\uff0c\u88ab\u8feb\u4e2d\u6b62\u6216\u5ef6\u9072\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u9032\u884c\u8a73\u7d30\u7684\u8cc7\u6e90\u898f\u5283\uff08\u8cbb\u7528\u3001\u4eba\u529b\u3001\u6642\u7a0b\uff09<\/li>\n<li>\u9810\u7559 30-50% \u7de9\u885d\u9810\u7b97\uff08\u61c9\u5c0d\u88dc\u4ef6\u6216\u984d\u5916\u6e2c\u8a66\uff09<\/li>\n<li>\u8003\u616e\u5206\u968e\u6bb5\u878d\u8cc7\u6216\u5c0b\u627e\u7b56\u7565\u5408\u4f5c\u5925\u4f34<\/li>\n<\/ul>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p><strong>\u95dc\u9375\u91cd\u9ede<\/strong>::<\/p>\n<ul>\n<li>FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u9078\u64c7\u53d6\u6c7a\u65bc\u7522\u54c1\u98a8\u96aa\u5206\u985e\u8207 Predicate Device \u53ef\u5f97\u6027<\/li>\n<li><strong>510(k)<\/strong>\uff1a\u6700\u5e38\u898b\u9014\u5f91\uff0c\u9069\u5408 Class II \u7522\u54c1\u4e14\u6709\u5408\u9069 Predicate\uff08\u6210\u672c\u4f4e\u3001\u6642\u9593\u77ed\uff09<\/li>\n<li><strong>De Novo<\/strong>\uff1a\u9069\u5408\u5275\u65b0\u7522\u54c1\u7121 Predicate\uff0c\u53ef\u5efa\u7acb\u65b0\u5206\u985e\u8207\u5e02\u5834\u5148\u6a5f\uff08\u4e2d\u7b49\u6210\u672c\u8207\u6642\u9593\uff09<\/li>\n<li><strong>PMA<\/strong>\uff1a\u9069\u7528 Class III \u9ad8\u98a8\u96aa\u7522\u54c1\uff0c\u9700\u5b8c\u6574\u81e8\u5e8a\u6578\u64da\uff08\u6210\u672c\u9ad8\u3001\u6642\u9593\u9577\u3001\u9580\u6abb\u9ad8\uff09<\/li>\n<li>\u9078\u64c7\u524d\u52d9\u5fc5\u78ba\u8a8d\u7522\u54c1\u5206\u985e\u3001\u8a55\u4f30 Predicate \u53ef\u5f97\u6027\u3001\u898f\u5283\u5145\u8db3\u8cc7\u6e90<\/li>\n<li>\u900f\u904e Pre-Submission Meeting \u8207 FDA \u78ba\u8a8d\u7b56\u7565\uff0c\u53ef\u5927\u5e45\u964d\u4f4e\u9000\u4ef6\u98a8\u96aa<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u9078\u64c7\u4ecd\u6709\u7591\u554f\uff0c\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/en\/\" target=\"_blank\" rel=\"noopener\">Green Circle Official Website<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; \u9078\u5c0d\u8def\u5f91\u662f\u6210\u529f\u95dc\u9375\uff1a\u4e09\u5927\u9014\u5f91\u9069\u7528\u60c5\u5883\u4e00\u6b21\u770b\u61c2 FDA \u91ab\u7642\u5668\u68b0\u4e0a\u5e02\u8def\u5f91\u9078\u64c7\u53d6\u6c7a\u65bc\u300c\u7522\u54c1\u98a8\u96aa\u5206\u985e\u300d [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"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":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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