...FDA年度工作汇总系列IIIFDA上市前批准（PMA）年度绩效情况汇总 上市前批准（PMA）是FDA基于科学和法规的原则来评估III类医疗器械安全性和有效性的过程。
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医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES
上市前批准管理 Pre-market Approval
的上市前批准 Pre-Market Approval ; PMA
这意味着他们不是作为已批准药物经过相同的上市前审核。
This means that they have not undergone the same premarket review as approved drugs.
这意味着它们没有作为已批准药物经过相同的上市前审核。
This means that they have not undergone the same premarket review as approved drugs.
在OTC类药物专著系统规定内，FDA允许一些OTC药物在没有获得批准前上市。
Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval.
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