Design Control Guidance - Food and Drug Administration

SECTION J. DESIGN HISTORY FILE (DHF)I. REQUIREMENTS§ 820.30(j) Design history file.• Each manufacturer shall establish and maintain a DHF for each type of device.• The DHF shall contain or reference the records necessary to demonstrate that thedesign was developed in accordance with the approved design plan and therequirements of this part.Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.16 Control ofquality records.II. DEFINITIONS§ 820.3(e) Design history file (DHF) means a compilation of records which describes thedesign history of a finished device.III. DISCUSSION AND POINTS TO CONSIDERThere is no specific requirement in ISO 9001 or ISO 13485 for a design history file.However, in order to market a medical device in the United States, a manufacturer mustcomply with the U. S. Food and Drug Administration (FDA) quality system regulation,which requires a design history file. For this reason, some guidance is provided on theU. S. FDA design history file.Other national regulations require some form of documentation and records. Productdocumentation required by Canada, Europe, and Japan contain certain elements of theU. S. FDA design history file requirements without requiring all the elements to becompiled in a file.Virtually every section of the design control requirements specifies information whichshould be recorded. The compilation of these records is sometimes referred to as thedesign history file. Throughout this guidance document, suggestions are made whenwarranted as to the form and content of documents contained in the design history file.The primary beneficiary of the device history file is the device manufacturer. For example,in one case, a microprocessor-controlled enteral feeding pump was reported to bebehaving erratically in the field. Some of the symptoms pointed to software problems. Butthe manufacturer admitted that they did not possess a copy of the software source codefor the product. The software had been developed by a contractor who had delivered onlya master EPROM (memory chip) which was duplicated by the manufacturer to install theSection J. Design History File 3/11/97 Page 43