It is important to mention that due to their legal nature, FDA guidance documents are non-binding, and are only intended to provide medical device manufacturers and other parties involved with additional clarifications regarding the current legislation, as well as recommendations to be considered to achieve and sustain compliance thereto. The authority explicitly states that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been agreed with the authority in advance.
Table of Contents
Regulatory Background
First of all, the document provides an excerpt from the applicable legislation, namely, § 820.3(j), which states that:
- 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 by the approved design plan and the requirements of this part.
The document also refers to the applicable standards, such as ISO 9001:1994 and ISO/DIS 13485 in terms of records related to quality control.
According to the official definition provided in the regulation, the Design history file (DHF) stands for a compilation of records that describes the design history of a finished device.
The FDA further explains that the aforementioned standards do not provide specific requirements about DHF. At the same time, the latter is required under the quality system regulation introduced by the FDA, which is mandatory for any medical device manufacturers intended to market their products in the US. Moreover, each element of the aforementioned requirements indicates the particular information to be kept by the manufacturer as a part of DHF. The present FDA guidance is intended to provide additional clarification regarding the scope of information to be recorded, as well as the form in which this information should be recorded to ensure compliance with the applicable regulatory requirements.
Design History File: Key Points
The device history file could be useful for the manufacturer when investigating the safety- and performance-related issues associated with medical devices it is responsible for. The guidance provides an example of a situation in which a malfunction was caused by a software failure. Because the software in question was provided by a third-party developer, and the manufacturer had no access to its source code, it was impossible to fix the issue, so the manufacturer had to initiate a recall covering all the devices placed on the market and supplied to customers. The FDA provides this example to demonstrate the importance of keeping records of all the design solutions implemented. The manufacturer can face the lack of product-related information due to numerous cases – for example, an agreement with a third-party supplier could be terminated, or an employee responsible for the particular aspects could leave the company. In this regard, the Agency states that since design decisions often directly affect the well-being of device users and patients, it is to the manufacturer’s benefit to maintain the knowledge base which forms a basis for the product design. In other words, the manufacturer shall at any time have exhaustive information about the medical device it is responsible for to be able to use this information when investigating the adverse events and deciding on corrective and preventive actions to be taken.
At the same time, the authority acknowledges that in most cases the design-related information is contained in numerous sources and media, such as personal notebooks used by design engineers, or in email correspondence. Moreover, such records could be created and kept by different departments depending on the functions they perform. The guidance provides an example of a situation when quality system plans applicable to a development project may reside in the quality assurance department, while the chief engineer may be responsible for maintaining design and development plans. To ensure the accessibility of this information, all such codes should be subject to consolidation. According to the guidance, all design-related information should be easily accessible for the manufacturer once needed. This aspect should be taken into consideration when developing the information exchange flows and procedures. The authority also mentions that in case an existing procedure meets the aforementioned needs, the manufacturer is not obliged to develop and implement new procedures.
For instance, to ensure control over the information kept in notebooks used in laboratories, some of the manufacturers introduce special policies regulating this aspect. According to the guidance, such a policy could prescribe that:
- Laboratory notebooks are the property of the manufacturer, not the individual;
- A separate notebook is to be maintained for each project, and surrendered to the engineering librarian after the engineer’s active participation in the project;
- Laboratory notebooks are to be surrendered if the employee leaves the company;
- Product development supervisors shall review the employees’ laboratory notebooks at specified intervals to ensure that records are complete, accurate, and legible.
It is also important to mention that current legislation does not provide specific requirements regarding the way the design history file should be organized. For instance, in case the design is quite simple, one responsible person will be able to keep all information in one place, while in cases when several teams are involved, the appropriate document control system will be necessary to ensure all information and documentation is stored in a structured way and is easily accessible when necessary.
Additional Recommendations
According to the guidance, the approach to be applied in the context of record-keeping should be determined depending on the complexity of the product development process. As it was mentioned before in examples with policies for employees’ notebooks, it could be initially prescribed that all design history documentation is the property of the manufacturer, not the employee or contractor. Moreover, the agreements the manufacturer enters into with third-party providers and subcontractors should explicitly outline the rights of the manufacturer about such information, and also the particular way it should be documented. The authority also encourages the manufacturers to keep all information related to the particular project in one place to ensure its accessibility. According to the guidance, such information could include:
- Detailed design and development plan specifying design tasks and deliverables,
- Copies of approved design input documents and design output documents,
- Documentation of design reviews,
- Validation documentation,
- When applicable, copies of controlled design documents and change control records.
In summary, the present FDA guidance highlights the most important aspects related to the design history and documentation associated thereto. The document describes the approach to be applied by a manufacturer to ensure the availably of all important information regarding the design solutions implemented and decisions taken.
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