美国医疗设备捆绑政策。
The US medical device bundling policy.
作者信息
Donawa Maria
机构信息
Donawa & Associates Ltd., Rome, Italy.
出版信息
Med Device Technol. 2004 Nov;15(9):25-7.
PMID:16231784
Abstract
Companies preparing United States (US) premarket submissions should be aware of a US policy that may save them time and money. This policy allows the grouping or "bundling" of multiple devices or multiple indications for use in a single submission. This article discusses this policy and a US guidance document that explains when bundling is appropriate.
摘要
准备美国上市前申报材料的公司应了解一项可能为他们节省时间和金钱的美国政策。这项政策允许在单一申报中对多个设备或多个使用适应症进行分组或“捆绑”。本文讨论了这项政策以及一份解释何时适合捆绑的美国指导文件。
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