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FDA 510(k) 注冊(cè)流程 FDA是食品藥品監(jiān)督管理局（Food and Drug Administration）的簡(jiǎn)稱。FDA有時(shí)也代表美國(guó)FDA，是國(guó)際醫(yī)療審核權(quán)威機(jī)構(gòu)，由美國(guó)國(guó)會(huì)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(duì)于生產(chǎn)II類醫(yī)療器械的生產(chǎn)商來(lái)說(shuō)，需要在美國(guó)食品藥品管理局(FDA) 申請(qǐng)市場(chǎng)準(zhǔn)入，即FDA 510K申請(qǐng)。只有通過(guò)美國(guó)FDA注冊(cè)認(rèn)證，才能獲得在美國(guó)合法的銷售許可。 Time:2018-6-29 11:34:46 View:2397