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An Entity of Type : prov:Entity, within Data Space : webisadb.webdatacommons.org associated with source dataset(s)

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  • The scope should be based on the Essential Requirements that need to be addressed from a clinical perspective considering whether any device design features or target treatment populations require special attention; whether data from equivalent devices can be used to support the safety and/or performance of the device; and the data sources and types of data to be used in the clinical evaluation.
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