Product Group Identifier

Specifies whether the product group is real (actual) vs. placeholder (kind of).

A collection of instances of a product.

A regulatory plan or strategy submitted to the FDA proposing the approval of a new device for marketing in the U.S. …

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.