The device master record contains current device specifications and. 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. Proprietary information in this index is replaced by x's. The device master record is a regulatory requirement for all medical device companies. 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,.
