{"id":1097,"slug":"宣传页上写着-美国fda注册机构-是不是意味着通过了fda批准","question":"宣传页上写着\"美国FDA注册机构\"，是不是意味着通过了FDA批准？","intent":"informational","language":"zh","url":"https://worldwiki.io/q/宣传页上写着-美国fda注册机构-是不是意味着通过了fda批准","entity":{"slug":"cell-banking","name":"Cell Banking","url":"https://worldwiki.io/entity/cell-banking"},"answer":{"short_answer":"不是。FDA明确说明，登记（registration）只表示该机构把自己的经营情况告知了FDA，并不构成FDA的认可或批准。美国的私营脐带血库必须登记并遵守供者筛查、传染病检测和现行良好组织操作规范，但登记本身不评价其产品或服务。把\"注册\"等同于\"批准\"是宣传中最常见的偷换概念。","detailed_answer":null,"format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"id":261,"title":"Cord Blood Banking - Information for Consumers","url":"https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/cord-blood-banking-information-consumers","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-19 18:00:28"},{"id":112,"title":"Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes","url":"https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:49"}],"published_at":"2026-09-20 08:11:10"}