Regulatory Open Forum

I have been falling down the rabbit hole of regulations on thermometers.  Many wearable devices use creative wording like "skin heat sensing" or "body temperature tracking" but they are nowhere to be found as FDA registered/listed devices.  When is a thermometer no longer a medical device?  Perhaps the temperature is sent to the cloud for a doctor to review, or the output is a happy or sad face emoji instead of a value...but I assume FDA would still likely say you're diagnosing fever.  Are these companies just giving the consumer some nice-to-know info about the temp of their skin for general wellness purposes?

I realize that some companies are marketing many of their wellness device claims like sleep monitoring and step counting, and when digging a little deeper on their websites it's clear the thermometer feature is not available in the US (though some have a 'how to hack your device to uncover additional features' page).  FDA regulates "clinical electronic thermometers" as a Class II, 510(k) devices (procode FLL).  Interestingly, fertility monitors that measure basal body/skin temperature are 510(k) exempt (procode LHD).  And then there's the "clinical color change thermometer" which is Class I, 510(k) exempt. 

I guess my question is, for all these companies that have creative interpretations of the definition of a thermometer, are they likely just lining up for a warning letter or is there something I'm missing here? 

I have been falling down the rabbit hole of regulations on thermometers.  Many wearable devices use creative wording like "skin heat sensing" or "body temperature tracking" but they are nowhere to be found as FDA registered/listed devices.  When is a thermometer no longer a medical device?  Perhaps the temperature is sent to the cloud for a doctor to review, or the output is a happy or sad face emoji instead of a value...but I assume FDA would still likely say you're diagnosing fever.  Are these companies just giving the consumer some nice-to-know info about the temp of their skin for general wellness purposes?

I realize that some companies are marketing many of their wellness device claims like sleep monitoring and step counting, and when digging a little deeper on their websites it's clear the thermometer feature is not available in the US (though some have a 'how to hack your device to uncover additional features' page).  FDA regulates "clinical electronic thermometers" as a Class II, 510(k) devices (procode FLL).  Interestingly, fertility monitors that measure basal body/skin temperature are 510(k) exempt (procode LHD).  And then there's the "clinical color change thermometer" which is Class I, 510(k) exempt. 

I guess my question is, for all these companies that have creative interpretations of the definition of a thermometer, are they likely just lining up for a warning letter or is there something I'm missing here? 

I have been falling down the rabbit hole of regulations on thermometers.  Many wearable devices use creative wording like "skin heat sensing" or "body temperature tracking" but they are nowhere to be found as FDA registered/listed devices.  When is a thermometer no longer a medical device?  Perhaps the temperature is sent to the cloud for a doctor to review, or the output is a happy or sad face emoji instead of a value...but I assume FDA would still likely say you're diagnosing fever.  Are these companies just giving the consumer some nice-to-know info about the temp of their skin for general wellness purposes?

I realize that some companies are marketing many of their wellness device claims like sleep monitoring and step counting, and when digging a little deeper on their websites it's clear the thermometer feature is not available in the US (though some have a 'how to hack your device to uncover additional features' page).  FDA regulates "clinical electronic thermometers" as a Class II, 510(k) devices (procode FLL).  Interestingly, fertility monitors that measure basal body/skin temperature are 510(k) exempt (procode LHD).  And then there's the "clinical color change thermometer" which is Class I, 510(k) exempt. 

I guess my question is, for all these companies that have creative interpretations of the definition of a thermometer, are they likely just lining up for a warning letter or is there something I'm missing here? 

I have been falling down the rabbit hole of regulations on thermometers.  Many wearable devices use creative wording like "skin heat sensing" or "body temperature tracking" but they are nowhere to be found as FDA registered/listed devices.  When is a thermometer no longer a medical device?  Perhaps the temperature is sent to the cloud for a doctor to review, or the output is a happy or sad face emoji instead of a value...but I assume FDA would still likely say you're diagnosing fever.  Are these companies just giving the consumer some nice-to-know info about the temp of their skin for general wellness purposes?

I realize that some companies are marketing many of their wellness device claims like sleep monitoring and step counting, and when digging a little deeper on their websites it's clear the thermometer feature is not available in the US (though some have a 'how to hack your device to uncover additional features' page).  FDA regulates "clinical electronic thermometers" as a Class II, 510(k) devices (procode FLL).  Interestingly, fertility monitors that measure basal body/skin temperature are 510(k) exempt (procode LHD).  And then there's the "clinical color change thermometer" which is Class I, 510(k) exempt. 

I guess my question is, for all these companies that have creative interpretations of the definition of a thermometer, are they likely just lining up for a warning letter or is there something I'm missing here?