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FDA 510(k) 注冊流程 FDA是食品藥品監(jiān)督管理局（Food and Drug Administration）的簡稱。FDA有時(shí)也代表美國FDA，是國際醫(yī)療審核權(quán)威機(jī)構(gòu)，由美國國會即聯(lián)邦政府授權(quán)，專門從事食品與藥品管理的最高執(zhí)法機(jī)關(guān)。對于生產(chǎn)II類醫(yī)療器械的生產(chǎn)商來說，需要在美國食品藥品管理局(FDA) 申請市場準(zhǔn)入，即FDA 510K申請。只有通過美國FDA注冊認(rèn)證，才能獲得在美國合法的銷售許可。 Time:2018-6-29 11:34:46 View:2727