Pacif-i is not a medical device for Europe, Canada or the United States. That is it is not a device intended to be used in a clinical setting or for the diagnosis or treatment of an illness. Pacif-i is intended to be used as a "general wellness device" or as a "parental aid". It has been cleared by our Notified Body in the UK as not being a medical device for Europe and by Health Canada as not being a medical device in Canada. It falls within the FDA Guidance for "General Wellness: Policy for Low Risk Devices"
Does this mean I cannot use Pacif-i if my baby is ill?
Pacif-i can be used if your baby is ill, absolutely. Pacif-i will still provide you valuable information on your baby's temperature during a period when they are ill. But Pacif-i is not intended to be used to diagnose whether your baby is ill or to be used to determine whether to administer them any medicine. A clinical thermometer should be used for these purposes.
The Pacif-i App has a useful manual temperature feature where you can enter any temperature from a clinical thermometer. It also has a reminder feature to remind you when to take a temperature and also when to administer medication. This data can be shared with medical experts, but it is important that the temperature data you are sharing with them for diagnosis or treatment purposes is sourced from a clinical thermometer, and not from Pacif-i.
Do you intend to register Pacif-i as a medical device?
We do not intend to register Pacif-i as a medical device at this time.
I know of other pacifiers with temperature measuring functions that are medical devices, what makes Pacif-i different?
Pacifiers with temperature measuring functions can be medical devices if they are intended to be used in clinical settings or for the diagnosis or treatment of an illness. Some manufacturers make this claim in relation to their devices, in which case their device needs to be registered as a medical device.