The food and drug administration (fda) requires manufacturers of medical devices to create and maintain a device master record (dmr). The model of the dmr table should have a formal index form as. 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,. Okay, here is a generic example of a dmr template for a medical device. The requirement for a device master record is outlined in the fda’s quality system.