This document is a device master record index for an in vitro diagnostic product. The food and drug administration (fda) requires manufacturers of medical devices to create and maintain a device master record (dmr). A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device. Section 820.3(j) of the federal. A lot of the documents are not in the device master record, but are referenced in the dmr as to where the document is located (document control office, engineering library,.
