医疗器械FDA认证III类产品为“上市前批准管理（Pre-market Approval，PMA）”产品，是指具有较高风险或危害性，或是支持或维护生命的产品，例如人工心脏瓣膜、心脏起搏器、人工晶体、...
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The FDA requires clinical trials for the riskiest devices through its pre-market approval process.
食品及药物管理局要求风险最大的医疗设备在通过市场审批手续之前进行临床试验。
The main effect of DSHEA was to remove certain dietary ingredients from regulation as food additives, which requires pre-market approval.
健康教育法案(DSHEA)主要作用是在某种食材的售前批准程序中，撤销某种作为食品添加剂的材质。
"Unlike prescription and over-the-counter drugs, the law does not require nutritional supplements to undergo pre-market approval for safety and efficacy," the researchers wrote.
与处方及非处方药不同，法律并没有要求营养补品在上市前通过安全和有效性检验。“研究者们写道。”
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