On August 5, the Food and Drug Administration (FDA) issued a guidance entitled “Design Considerations for Devices Intended for Home Use.” The guidance provides device manufacturers with recommendations to minimize safety and effectiveness risks associated with devices that are intended to be used in the home. The FDA defines “home use device” as “a medical device labeled for use in any environment outside a professional healthcare facility. This includes but is not limited to outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes. If the device is intended to be used in professional healthcare facilities and also outside those facilities, it meets this definition.” The guidance applies to prescription and over-the-counter devices, including class I, II, or III devices. The guidance contains recommendations for designing and developing home use devices that pertain to the physical environment, the user, the device or system, human factors and labeling:
- Environment: The FDA notes that the labeling of a device may include warnings against using a device in environmental conditions that may impact safety or effectiveness. Nonetheless, the FDA prefers that device manufacturers manage risks through device design rather than labeling. The FDA recommends that device manufacturers include in their premarket submissions a summary of the efforts taken to account for location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, air flow, travel and international use, fluid exposure and storage.
- Users: The FDA recommends that manufacturers consider patients’ different physical, sensory/perceptual, cognitive and emotional abilities.
- Device or System Design: The FDA’s guidance references the Quality System regulation (21 CFR Part 820), which includes requirements that are intended to help ensure that medical devices are safe and effective. The FDA highlights that the requirements related to design controls are especially important for home use devices. The FDA suggests that device manufacturers consider developing a risk management plan. It also provides recommendations related to using lock-out mechanisms to control access to certain device functions, as well as maintenance, calibration, mechanical and electrical issues.
- Human Factors: The FDA indicates that device manufacturers need to conduct human factors engineering to understand how people will use and interact with the device and to identify design issues that may affect the safety and efficacy of the device. The FDA warns manufacturers that users may not understand multiple steps, may not receive sufficient training on how to operate the device, and may not be able to comprehend multiple warnings and precautions. Similarly, users may not understand requirements related to calibrating, cleaning, and maintaining the device. The FDA recommends that manufacturers consider the need for training when they are determining the complexity of the device. In addition, the FDA recommends that manufacturers specify responsibilities of a care partner, caregiver, and the care recipient during training sessions and provide instructions on emergency procedures. The FDA also recommends that manufacturers provide the user with information on retraining or recertification needed for the safe operation of the device.
- Labeling: The FDA explains that the labeling for home use devices is required to satisfy the applicable regulatory requirements in 21 CFR Part 801 and 809.10. The FDA highlights that the labeling for users should be visible, simple, concise and easily understood. Although the labeling is important, the FDA notes that the device or system should be designed so that it is “inherently apparent to users.” The FDA also provides recommendations on information that should be provided to the user related to handling the device in an emergency, the proper disposal of the device and its accessories, and hygienic maintenance of the device.
The guidance also describes postmarket considerations, including customer service and requirements related to medical device reporting. The guidance is available here.
The FDA’s guidance contains non-binding recommendations, and represents the FDA’s current thoughts about how device manufacturers can minimize the safety risks associated with home use devices. In addition to focusing on the FDA’s requirements and recommendations, we encourage device manufacturers early in the development process to consider how the product should be reimbursed. Just because a device satisfies the FDA’s requirements does not mean that the device will qualify for reimbursement. For example, the Medicare Part B benefit for durable medical equipment, prosthetics, orthotics and supplies provides coverage and reimbursement for certain medical devices used in a patient’s home. In order to be covered under this benefit, a medical device must satisfy the definition of “durable medical equipment” by being equipment that:
- Can withstand repeated use.
- Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years.
- Is primarily and customarily used to serve a medical purpose.
- Generally is not useful to an individual in the absence of an illness or injury.
- Is appropriate for use in the home.