The food and drug administration (fda) requires manufacturers of medical devices to create and maintain a device master record (dmr). Proprietary information in this index is replaced by x's. 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 device master record is a regulatory requirement for all medical device companies. 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.
