A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.

• A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
• A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

In November 2010 industry leaders came together to consider how a group might be formed to lead the way in the formulation of dedicated international standards, in cooperation with established standard bodies.

• To assist in the development of international standards and regulations relating to safe and effective home use, light- and energy-based aesthetic devices
• In advance of the publication of standards, to develop best practice recommendations, starting with safety
• To encourage and disseminate communications about the efficacy and safety of home-use, light- and energy-based aesthetic devices

KEY MESSAGES

• HUDs (prescription versions) are seen as a complement of Rx regimen
• HUDs (cosmetic variants) are seen as a complement to cosmetic procedures as part of anti-aging regimen (procedures + skincare + HUDs)
• HUDs are perceived as a door opener for professional cosmetic procedures