In reading 820.181 and the fda guidance for device master record i cannot find any actual requirement for a controlled document called a dmr index. 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,. The food and drug administration (fda) requires manufacturers of medical devices to create and maintain a device master record (dmr). Okay, here is a generic example of a dmr template for a medical device. The document defines four types of records that are important for medical device development and manufacturing:
