Don’t blame FDA for everthing. The don’t mandate how long the sensors can be used. They only review and approve the data submittted by the firm. If the data submitted by Dexcom supported a longer lifespan, FDA would review that and approve if the device proved it was safe and effective for that extended time period. We all know that most sensors last wel beyond the 7 days they are approved for, but some do not. Those that don’t, are replaced under warranty. If Dexcom claimed a 14 day lifespan, they would have to replace every sensor that didn’t make it that long. The technology is just not there yet.
David, my understanding was that FDA does not allow any external device or tube to be attached to the skin for more than 7 days right now. This is why Dexcom must declare the 7 days maximum lifespan for a sensor. I could be wrong though, I am not sure of my sources.
You’re right about the additional liability that Dexcom would take if they would declare say, 10 days of life span instead of just 7, there might be more cases of people complaining when the sensor quit working properly after 9 days. The technology is getting there anyway, and I am sure Dexcom is gathering a lot of experience and will make better and more reliable sensors moving forward.
Ciao, Luca