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Product Development Protocol
A regulatory plan or strategy submitted to the FDA proposing the approval of a new device for marketing in the U.S. It includes a demonstration of the safety and efficacy of the device. (NCI Thesaurus)
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Submissions not covered by the other eCTD submission types. These generally would be administrative type submissions such as meeting requests, change of…
A coded value specifying a group of products that are homogeneous or generally considered as substitutes for each other. The class is…
Terminology used in Individual Case Safety Reports to describe a product characteristic.
The time delay between and adverse event and a product action taken relationship.
Specifies the link between an adverse event and the steps performed with the product to address it.
The end result of a manufacturing process; anything that is produced.
