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Everything You Always Wanted to Know about Medical Device Requirements and Weren't Afraid to Ask. Fourth Edition.

机译:您一直想知道的关于医疗设备要求的一切,并且不要害怕问。第四版。

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摘要

The booklet explains the general regulatory requirements that manufacturers must consider when they manufacture, market, or distribute a medical device. The information is useful for guidance and reference in such regulatory areas as Establishment Registration, Premarket Notification, Premarket Approval, Investigational Device Exemptions, and Good Manufacturing Practices. It is not an official statement of policy binding FDA.

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