FDA
Human Factors Requirements
As a manufacturer,
you are required by FDA (and other international regulatory bodies) to demonstrate
how human factors considerations were met during your product's development. To
assist manufacturers in understanding the regulations, FDA has issued several
guidance documents to support its human factors initiative, including Do
It By Design: An Introduction to Human Factors in Medical Devices and Medical
Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.
However, the "teeth" behind their human factors requirements lay in
Section 820.30 of the QSR, in paragraphs c, f, and g:
(c) Design Input:
| | "Each manufacturer
shall establish and maintain procedures to ensure that the design requirements
relating to a device are appropriate and address the intended use of the device,
including the needs of the users and patient." | |
FDA's goal is to ensure that manufacturers make a
systematic assessment of who will be using a device (user population), the conditions
under which it will be used (use environment, situational factors), how it will
be used (tasks, usage scenarios for the full life of the product), and whether
there are use-related hazards (can it be used safely). Human
factors activities for generating design inputs include things like user
research studies (focus groups, one-on-one interviews, contextual inquiry),
task analysis, Usability & Safety Bench Tests,
and usability testing of design concepts.
(f) Design Verification:
| | "Each manufacturer
shall establish and maintain procedures for verifying the design input. Design
verification shall confirm that the design output meets the design input requirements."
| | Verification pertains
to inspection, analysis, and testing of your device against requirements. Human
Factors techniques for verification include Usability
& Safety Bench tests and usability
testing.
( g ) Design validation:
| | "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." | |
Validation addresses the broader issue of whether
the device can be used safely in real-world situations. FDA expects you to conduct
usability testing with actual users under
simulated (but as real as possible) conditions, using production or pre-production
models. The primary human factors techniques for
design validation is usability testing.
Paragraph (g) also references risk analysis:
| | "Design
validation shall include...risk analysis...." | |
Throughout product design and development, FDA expects
manufacturers to engage in risk management. The human factors focus for risk management
is on so-called use-related errors. Risk management of use-related errors involves
identifying and describing use scenarios that result in hazards, assessing risk,
introducing user interface design changes that eliminate or mitigate risk, verifying
that design changes do mitigate risk and that no new hazards are introduced, and
validating that the final device can be used safely and effectively. These goals
can usually be met as part of the task analysis, expert review, and usability
testing activities discussed above. FDA expects investments
in human factors by manufacturers to be commensurate with a device's inherent
risk: the greater the risk associated with error, the more human factors effort
is warranted. However, there are no hard and fast rules (only guidelines) and
in the end, it's up to the company to decide what human factors work to conduct
during product development. Device manufacturers need to be satisfied that what
they have done is sufficient to ensure that their device can be used safely and
effectively, and that they can justify their level of human factors effort to
FDA if asked. For more information about FDA's Human
Factors Program, you can visit their Human
Factors Portal. To find out whether your human factors initiatives meet FDA
requirements, contact us.
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