Design history file
Encyclopedia
Design History File is a compilation of documentation
that describes the design history of a finished medical device
. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient
. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control
records of the device.
s manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the development of a new product, and a design history file where these activities are documented. These controls are specifically intended to manage a medical device company's new product development
activities. Research and development
processes aimed at developing new underlying technologies are not subject to these regulations. The requirements for a DHF are documented in FDA Regulation CFR 21
820..
include:
Document
The term document has multiple meanings in ordinary language and in scholarship. WordNet 3.1. lists four meanings :* document, written document, papers...
that describes the design history of a finished medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient
Patient
A patient is any recipient of healthcare services. The patient is most often ill or injured and in need of treatment by a physician, advanced practice registered nurse, veterinarian, or other health care provider....
. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control
Quality control
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...
records of the device.
Requirements
The regulation requires of medical deviceMedical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the development of a new product, and a design history file where these activities are documented. These controls are specifically intended to manage a medical device company's new product development
New product development
In business and engineering, new product development is the term used to describe the complete process of bringing a new product to market. A product is a set of benefits offered for exchange and can be tangible or intangible...
activities. Research and development
Research and development
The phrase research and development , according to the Organization for Economic Co-operation and Development, refers to "creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of...
processes aimed at developing new underlying technologies are not subject to these regulations. The requirements for a DHF are documented in FDA Regulation CFR 21
Title 21 of the Code of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration , the Drug Enforcement Administration , and the Office of National Drug Control Policy ....
820..
Design controls
Each manufacturer of either a class II or class III medical device (as well as a select group of class I devices) needs to establish and document procedures on the design and design requirements. These design controlsDesign controls
Design Controls designates the application of a formal methodology to the conduct of product activities.It is often mandatory to implement such practice when designing and developing products within regulated industries Design Controls designates the application of a formal methodology to the...
include:
- Design input - Design inputs are typically the initial requirements that describe the medical device to be produced.
- Design output - Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. Including the manufacturing process and the in-coming, in-process and finished device inspection, measurement or test methods and criteria. The outputs are normally documented in models, drawings, engineering analysis and other documents. The output needs to be directly traceable to the input requirements. Design verification and validation should demonstrate that the final output specifications conform to the input requirements and meet user needs and intended uses.
- 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 conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. 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 product development (PD) process or an index of documents and their storage location.