The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.
In 1990, the FDA mandated the design history file(DHF) as part of the safe medical devices act. It contains all of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.
Overview of 21 CFR part 820
The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.
Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.
Subsection j) of 21 CFR part 820 says:
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 the design was developed in accordance with the approved design plan and the requirements of this part.”
DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. 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 go a long way towards helping you pass your next FDA audit.
Here are some key interpretations of the DHF guidance that medical device companies should take note of:
A DHF must be maintained for each type of device that you manufacture. For similar versions of the same device, you can include all of the data in a single DHF.
The DHF demonstrates that the device was developed in accordance with both the design plan andthe requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF.
The DHF must either contain or reference the necessary documents, which means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.
What belongs in your DHF?
Below, we’ve listed the steps of the design controls process and what documents should be included with each step:
Design input: include your design plan document, developed according to this part.
Design output: Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. The outputs are normally documented in models, drawings, engineering analyses, and other documents.
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. The design review must be documented in the DHF and include review date, participants, design version/revision reviewed, and review results.
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.
Process validation: is the process in which the device design is validated using initial/low volume production processes. The purpose of the process validation is to confirm that the design functions according to design inputs when produced using normal production processes rather than prototype processes.
Design validation: Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall 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.
FDA Staff (October 7, 1966). “Part 820 ”. Federal Register. 61 (195): 52657. ISBN9781932074109. Retrieved January 13, 2017. Also available in hardcopy, as FDAnews (2003). Device Inspections Guide. Washington, DC: Washington Business Information. p. 52657. ISBN1932074104.
The device master record (DMR) is the compilation that contains all the information and specifications needed to produce a medical device from scratch to finish. Should include the instructions for all manufacturing processes, drawings, documented specifications, and, packaging requirements. While the device history record makes reference to specific lots, units, or batches of product, the DMR contains specifications for producing an individual device.
The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which handles record-keeping requirements for medical device companies.
When the FDA audits your medical device company, you will be expected to produce a DMR that complies with 21 CFR Part 820.181. Here’s the full text of that part for reference:
Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
d) Packaging and labeling specifications, including methods and processes used; and
e) Installation, maintenance, and servicing procedures and methods.
The main purpose of the DMR is to centralize a record of the production process in a way that distinguishes it from the design process. A product engineer might design a silicone part for a medical device and include it in the design outputs portion of the design history file, but the DMR would also include specific instructions for manufacturing the part, including what mold to use, equipment specifications and production methods.
The good news is that the FDA requires you to only reference the mandated items, not duplicate them. If you’ve been organized in creating your DHF, you’ll be able to easily reference that location in your DMR.
Difference between DHF and DMR
The difference between the DHF and the DMR is about design vs device. The design history file is focused on capturing the history of the design and ensuring that it was done according to FDA regulation. The device master record is focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.
An industrial designer develops the concepts for manufactured products, such as machines, medical devices, toys, electronics, and more. They combine art, business, and engineering to make products that people use every day. They work in offices in a variety of industries. Although they design manufactured products, only about 29% of industrial designers are employed directly by manufacturers.
An industrial designer will typically do the following:
Research who will use the product and the various ways it might be used
Sketch out ideas or create blueprints
Use computer software to develop virtual models of different designs
Examine materials and production costs to determine manufacturing requirements
Work with other specialists to evaluate whether their design concepts will fill the need at a reasonable cost
Evaluate product safety, appearance, and function to determine if a design is practical
Present designs and demonstrate prototypes to clients for approval
Industrial designers generally focus on a particular product category. For example, some design medical equipment, while others work on consumer electronics products. Other designers develop ideas for new bicycles, furniture, housewares, or snowboards. They imagine how consumers might use a product and test different designs with consumers to see how each design looks and works.
Industrial designers often work with engineers, production experts, and marketing specialists to find out if their designs are feasible and to apply their colleagues’ professional expertise to their designs. For example, industrial designers may work with marketing specialists to develop plans to market new product designs to consumers.
The establishment of device history records (DHR) is one of the last steps in the compliance process for medical devices. It falls under subpart M of 21 CFR Part 820, which deals with general record-keeping requirements for medical device companies. The FDA mandates that all medical device companies should have the documentation related to manufacturing and tracking according to the information in the device master record.
Manufacturers are subject to this part whether they keep records on paper, or use web-based software. The DHR serves as a production record for medical devices that you manufacture. The entries into this document must include acceptance records for individual units or batches of product, along with product counts, labels, and any unique product identifiers that have been applied.
Most sections of 21 CFR Part 820 refer to establishing overall quality processes that affect your product design and manufacturing, but the DHR is different in that it is applied to each batch of products that you produce.
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
The DHR mandate requires that new batches of products are tested to ensure that they meet the product specifications established in the device master record. The mandate also ensures that batches of products are correctly labeled and assigned identification numbers. This creates traceability throughout your supply chain, enabling you to better identify sources of error in case any non-conformance issues arise with your products.
Benefits of the DHR
Complaints: If a non-conformance issue or customer complaint is presented to your CAPA team, the team can determine the UDI, UPC, or other product identifier associated with the complaint. This allows your team to identify potentially problematic batches or production runs of devices and find the root cause of the issue. This allows your quality manager to determine whether non-conformance issues were confined to a specific batch of product, or if the issue is affecting products in all batches.
Process improvement: Imagine that a batch of product passes your acceptance criteria, but is later found to contain a proportion of the non-conforming product. The ability to trace non-conformance issues back to a specific batch can help you understand the problem and redesign your acceptance criteria to prevent future occurrences of the defect.
Limit liability and save money: The DHR allows manufacturers to demonstrate that batches of the product were tested for acceptance with the DMR before being released for distribution. It also allows targeted recalls if only a certain batch is found to be defective. Imagine you release 1,000 batches of product for distribution and receive 10non-conformance complaints from the same batch. Referencing your DHR, you’ll realize that it’s just a single batch that has defects, and you can issue a targeted recall of that batch instead of recalling all 1,000.
Each manufacturer shall establish and maintain procedures to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
ISO 13485:2016 also covers this topic in section 7.3.3 Design and Development Inputs:
Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, and safety requirements, according to the intended use, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, d) other requirements essential for design and development, and e) output(s) of risk management
These inputs shall be reviewed and approved.
Requirements shall be complete, unambiguous, and not in conflict with each other.
There are several terms used interchangeably when referring to design inputs:
Design input requirements
Design and development requirements
Medical device product development should be a holistic process that builds upon itself as the project progresses.
Rushing the product to the market isn’t a recommended best practice in medical device development. Spending time in design inputs will really benefit your project. In device development, establishing design inputs can easily take up to 20% of the entire project timeline.
Writing design inputs takes practice and dedication. Also, design inputs should not just be the responsibility of one person. It’s a team effort. When a team is involved, you get the benefit of everyone’s opinions and experience.
You also should consider all sorts of other sources to help you define design inputs:
It’s important to remember that user needs should be established first in order to inform design inputs. Your goals when defining design inputs include:
Capturing all functional, performance, safety, and regulatory requirements.
Build upon user needs and intended use.
Make sure design inputs are clear and objective.
State design inputs in a way that allows you to prove/disprove them.
You have to consider all types of sources and resources for design inputs. Your design inputs need to be comprehensive, covering all aspects of your medical device.