A certificate of compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements... View more
A certificate of compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) is required for registration of a Newly Notified Medical Device.
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Overview of Medical Device Design History File (DHF)
Overview of Medical Device Design History File (DHF)
What is Design History File (DHF)?
A 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.
The creation of a DHF is the last step in the design controls process mandated by the FDA in 21 CFR Part 820. While the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards, the DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF goes a long way towards helping you pass your next FDA audit.
There are no specific requirements saying how you must organize your design history file or where you must store it. For simple products the design engineer may assemble and maintain the entire DHF. However, for larger projects you will most likely need a document control system housed in a centralized location. Your DHF and associated documents are an important part of any US FDA 510(k) or PMA submission.
Device master record (DMR)
The DHF shows how you developed your recipe, but the DMR is the recipe itself. In other words, it contains all the information needed to produce the device. Section 820.181 of the FDA QSR is specific about what the device master record should contain, including:
Production process specifications
Quality assurance procedures and specifications, including acceptance criteria
Packaging and labeling specifications
Installation, maintenance, and servicing procedures and methods
In maintaining this information, it is really most important that you think of the DMR as the place where you can store files and link to other data sources rather than keeping everything in the DMR itself.
Device history record (DHR)
Continuing our cooking analogy, the device history record (DHR) is demonstrable proof that you followed the recipe, namely your DMR. It’s required by the FDA, but ISO 13485:2016 contains no such requirement. FDA specifies that your DHR must include the date of manufacturing for each batch, lot, or unit; the number you manufactured; the quantity released for distribution; the labeling used for each production unit; plus any UDI, UPC, or other identification used.
You must also include your acceptance records, which show that you followed the recipe. Your DHR is particularly important during audits because the investigator may want to see your DHR and compare it against your DMR for compliance. If you are using a contract manufacturer, make sure your contract and device history record specify who reviews and releases the device.
What are the FDA Guidelines for DHF?
The design history file requirements live in 21 CFR Part 820.30, which contains the regulations for the design controls process. You’ll have to refer to subsection j)
j) 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 the design was developed in accordance with the approved design plan and the requirements of this part.
What Belongs in DHF?
Your DHF should contain all of the documentation created during the product development phase of your medical device. Following the mandated design controls process closely will help you understand what documents are required, as each step generates its own documentation.
As you go through the design and development process for your medical device, the documentation that you create is going to be contained here. According to the FDA, the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device.
The actual idea of the DHF is fairly straightforward. In practice, that can be a bit of a challenge if you don’t compile it as you go. You need to include or provide a reference to all of the records related to the activities you did during the design and development process.
That means you need all of the user needs and design inputs you came up with at the start of the project. All of the design outputs that you generated to build the device. All of the design verification and validation protocols and reports. Plus, all of the design reviews that went along with all of that…and don’t forget everything for transferring the device to manufacturing too.
If you’re using a paper-based QMS, you’re going to need to get a really big binder – or two. Once you’ve gotten all of those documents compiled into your DHF, the next acronym that needs to be tackled is the DMR.
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