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Sec. 820.30j Design Controls. |
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(j) 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. Interpretation:
There is no specific requirement in ISO 9001 or ISO
13485 for a design history file. However, in order to market a medical device
in the United States, a manufacturer must comply with the U. S. Food and
Drug Administration (FDA) quality system regulation, which requires a design
history file. For this reason, some guidance is provided on the U. S.
FDA design history file. Other national regulations require some form of
documentation and records. Product documentation required by Canada, Europe,
and Japan contain certain elements of the U. S. FDA design history file
requirements without requiring all the elements to be compiled in a file. Virtually every section of the design control
requirements specifies information which should be recorded. The compilation
of these records is sometimes referred to as the design history file.
Throughout this guidance document, suggestions are made when warranted as to
the form and content of documents contained in the design history file. The primary beneficiary of the device history file
is the device manufacturer. For example, in one case, a
microprocessor-controlled enteral feeding pump was reported to be behaving
erratically in the field. Some of the symptoms pointed to software problems.
But the manufacturer admitted that they did not possess a copy of the
software source code for the product. The software had been developed by a
contractor who had delivered only a master EPROM (memory chip) which was
duplicated by the manufacturer to install the software in each machine. The
contractor had subsequently withdrawn following a contractual dispute,
leaving the manufacturer with no rights to the source code developed by the
contractor, and no practical way to maintain the software. For this and other
reasons, the product was the subject of a mandatory recall and all known
units were collected and destroyed. This is admittedly an extreme case, but many
similar cases have been documented in which the manufacturer lacked design
information necessary to validate a design and maintain it throughout the
product life cycle. This occurs for the most innocent of reasons-contracts
expire, companies reorganize, employees move on to new projects or new jobs.
Even when the designer is available, he or she may forget why a particular
decision was made years, months, or even weeks before. 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. Except for small projects, it is unusual for all
design history documents to be filed in a single location. For example, many
design engineers maintain laboratory notebooks which are typically retained
in the engineers' personal files. In addition, the design history may include
memoranda and electronic mail correspondence which are stored at various
physical locations. 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. These diverse
records need not be consolidated at a single location. The intent is simply
that manufacturers have access to the information when it is needed. If a
manufacturer has established procedures for multiple filing systems which
together satisfy that intent, there is no need to create additional
procedures or records. As an example of the level of detail which may be
entailed, some manufacturers have policies covering laboratory notebooks.
Manufacturers typically find that without such written procedures, a
breakdown in communications eventually occurs, resulting in a loss of
control. These procedures might address the following points.
There are no requirements on the location or
organization of the design history file. In some cases, especially for simple
designs, the designer will assemble and maintain the entire design history
file. For larger projects, a document control system will likely be established
for design documents, and these files will likely be maintained in some
central location, usually within the product development department. Based on the structure (or lack thereof) of the
product development organization, more or less extensive controls will be
required. For example, company policy should state unequivocally that all
design history documentation is the property of the manufacturer, not the
employee or contractor. Design and development contracts should explicitly
specify the manufacturer's right to design information and establish
standards for the form and content of design documentation. Finally, certain
basic design information may be maintained in a single project file in a
specified location. This may include the following:
When applicable, copies of controlled design documents and change control records. |
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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