These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.
这些规定包括工厂的注册，医疗设备清单，质量系统，医疗设备报告，售前批准或者认可，商标及美国代理的要求。
Repackaging and relabeling of a device and specification development are defined as manufacturing in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers of Devices.
在联邦法规第21篇第820.3（o）节和第807 篇以及《器械制造商的企业注册与器械列表》中，均将器械的再包装和再标识以及技术说明制定行为定义为制造。
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