Jun 13 2022
When developing a new home use device, you should take the considerations in this FDA guidance into account and, to the extent possible, reduce or minimize risk to acceptable levels through device design.
For any premarket submission to FDA, you should ensure that the device is suitable for home use and provide in the submission data that demonstrate how you considered and addressed the relevant hazards and risks. This can help FDA determine whether applicable safety and effectiveness requirements have been met.
This guidance provides recommendations for minimizing the risks associated with home use devices by considering the user, the use environment, the device or system, human factors, and labeling.
In your premarket submission for your device design, you include a summary of the efforts you took to account for the following considerations, if they pertain to the intended use environment for your device. If some of the items do not pertain to the type of equipment you are designing, then you will not have to consider them in your device design.
Dampness and Humidity
Atmospheric Pressure Changes
Travel and International Use
If the home use device is not designed for ease of use and understanding, you increase the likelihood of misuse and non-use of the device. Home use devices should be designed to prevent reasonably-foreseeable misuse. You should consider that children or adults might interact with the device in inappropriate ways.
If a premarket submission is required, it should identify your intended users and include a summary of the actions you took to account for these characteristics.
When establishing design controls for home use devices, you should take into account considerations related to device performance and user needs in the home environment.
Under 21 CFR 820.30 -- Design Controls, a manufacturer must establish procedures to ensure that device design will translate into a device that performs properly according to its intended use and user needs. Design control requirements of the QS regulation apply to design and development of the device as well as its packaging and labeling (e.g., Instructions for Use), and its cleaning, disinfection, and sterilization procedures.
You should consider developing a risk management plan.
This risk management plan should describe the process for identifying hazards, estimating and evaluating the known risks, controlling the risks, and monitoring the effectiveness of the controls. In your risk analysis, special attention should be paid to the possible causes of use-related errors and failures, as home use devices are exposed to more hazards than are present in professional health care facilities and present greater potential for harm caused by user error.
Your risk management plan should also include elements to control risk that can enhance the ease of use for the intended user population based on human factors engineering methods.
It is important to note that labeling alone generally does not offer sufficient risk control for the home use environment because warning labels, especially lengthy ones, can be ignored by or confusing to the user.
Software plays a critical role in the operation of some devices.
For these devices, you should focus on developing device and software architecture and algorithms for performance, error detection, control, and recovery. When developing a home use device, you should broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods.
Human Factors Testing
Human factors engineering offers well-established methods to identify design issues that could affect medical device safety and efficacy. One particularly effective human factors method is to conduct “usability” testing.
Testing early in the design process and then several more times as the design evolves is an effective way to prevent user interaction problems from persisting into the later stages of the design process, at which point effective solutions to problems may be more limited and more expensive to implement.
When designing devices, you should take into account that users may not understand multiple steps, may receive minimal training or teaching on how to operate these devices, and may not be able to understand multiple warnings and precautions. In addition, users may not understand the need to calibrate, clean, and maintain the device. User training may be critical for safe operation of home use devices.
Labeling for home use devices must address all applicable requirements in 21 CFR Part 801 and 809.10. Labeling considerations should be for both prescription and OTC devices. In general, the IFU for the user should be simple, concise, and easily understood. Instructions written for the user should be written in a narrative format, and pictures may be helpful to explain instructional steps. Although instructions, labeling, and training can influence users to use devices safely and effectively, use of such material assumes that the user will remember or refer back to the information. These approaches are less effective than designing the system so that it is inherently apparent to users. The device’s labeling should include contraindications that clearly explain why any individual should not use the device, and clear warnings of all hazards that cannot be designed out. Using the same terms throughout the labeling to identify the device avoids confusion for the user. Labeling on devices should be simple, visible, and clear and readily understood by the user; it should also be able to withstand defacement or wear. In addition to developing clear and effective labeling for the device, you should consider situations when the device may be separated from the labeling and what end users need to do to access the labeling, such as finding it on a Web site or calling someone who may be able to help them with safe device operation.
Designing your home use device should result in a safer and easier-to-use device, minimize use error, and reduce the likelihood that adverse events will occur—the preferred outcome of a well-designed medical device.
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