Design history file

Design History File (DHF) is a document or documentation artifact used in the Medical Device industry.

The DHF was introduced in 1990 when the US Congress passed the Safe Medical Devices Act. This legislation gave the Food and Drug Administration (FDA) the authority to monitor and regulate Medical Device companies new product development processes. Prior to this legislation, FDA auditors were limited to examining the Production and Quality Control records.

The Regulation requires of Medical Devices manufacturers of Class II and Class III devices to implement Design Controls. These Design Controls consist of: These controls are specifically intended to manage a Medical Device companies Product Development (PD) activities aimed at developing and introducting new Products. Research and Development (R&D) processes aimed at developing new underlying technologies are not subject to these regulations.
 * 1) a Development and Control plan used to manage the development of a new Product and
 * 2) a Design History File where these activities are documented.

The requirements for a DHF are documented in FDA Regulation 21 CFR. The following is an overview of the key parts of a DHF.

Design Input
Design Inputs are typically the initial Requirements and Specification that describes the Medical Device to be produced.

Design Output
Design Outputs are the results of the design and engineering efforts. These include models, drawings, engineering analysis and other data. The intent is to capture that the design results meet or exceed the Requirements and Specification set forth in the Design Input.

Design Review
The Design Review is a formal review of the Medical Device design by representatives of each design function participating in the design efforts as well as other interested parties (e.g. Marketing, Sales, Manufacturing Engineering, etc.). The Design Review must be documented in the DHF and include Review Date, Participants, Design Version/Revision reviewed and Review Results.

Design Verification
Design Verification is the process that confirms that the Design Output meets or exceeds the Design Input. Design Verification must be documented in the DHF and include the Verification Date, Participants, Design Version/Revision verified, Verification Method and Verification Results.

Design Validation
Design Validation is the process in which the Device Design is validated using initial/low volume Production processes. The purpose for the Design Validation is to confirm that the Design functions according to Design Inputs when produced using normal Production Processes rather than Prototype processes. The Design Validation must be documented in the DHF.

Design Transfer
Design Transfer is the process in which the Device Design is translated into Production, Distribution and Installation specifications.

Design Changes
Design Changes is the process in which the Design changes are identified and documented. Also known as Engineering Change or Enterprise Change.

Design History File
The DHF is a formal document that is prepared for each Medical Device. The DHF can be either a collection of the actual documents generated in the PD process or an index of documents and their storage location.

A much more detailed description of these requirements may be found in FDA guidance documents, 21 CFR 820.