4 ms·

This is a great idea (and name!), but does this fall under FDA regulation? I haven't kept up with the FDA's current policy on medical apps.

NigelS 12y ago
I think you can get around the red tape if the app doesn't make medical recommendations. As long as it just tracks the data, I don't believe it would need to be registered as a type-2 medical device.
- mcmancini 12y ago
  But from the landing page: An individual's data can help adjust their medications, change eating patterns and maximize sleep schedules. That sounds like it's being used to guide treatment.
  - NigelS 12y ago
    You're right. I think it would be in the developers best interest to let the user make that call, instead of explicitly advertising it.
    - yatoomy 12y ago
      Changed the wording. So it explicitly stated a user would use the data vs us recommending
      - mcmancini 12y ago
        Probably not sufficient. The patient is still using it to guide medical decisions. It would be worthwhile to speak to someone familiar with Canadian medical regulations.
        icambron 12y ago
        I suspect you're right, but doesn't a weight scale help you make medical decisions too? Is that a medical device?
        mcmancini 12y ago
        For US market, a scale is a Class 1 medical device.
  - yatoomy 12y ago
    What if we dont recommend treatment...more so utilizing the analytics they dont track. We wouldn't recommend, every case is different. That is between the user and their medical professional
    - mcmancini 12y ago
      I would guess that collecting data in this case could still fall under regulatory preview, and that you would also need to qualify your sensors (Pebble) too. It really would be best to speak to someone familiar with Canadian medical device data. Much cheaper to do things right from the start (e.g., develop under IEC 62304) than to fix things later after getting a nasty gram from the Canadian FDA equivalent. Maybe through very careful marketing you can work around potential problems, or maybe not. I think that this project is in an area that requires an expert opinion, however.
moberemk 12y ago
I'll have to look into that; offhand would you happen to know if there are any similar laws in Canada currently?
- mcmancini 12y ago
  IIRC, Canada largely follows CE. One other problem might be that you're using the Pebble sensors, and so that could fall under regulatory purview too.

NigelS 12y ago

I think you can get around the red tape if the app doesn't make medical recommendations. As long as it just tracks the data, I don't believe it would need to be registered as a type-2 medical device.

mcmancini 12y ago
But from the landing page: An individual's data can help adjust their medications, change eating patterns and maximize sleep schedules. That sounds like it's being used to guide treatment.
- NigelS 12y ago
  You're right. I think it would be in the developers best interest to let the user make that call, instead of explicitly advertising it.
  - yatoomy 12y ago
    Changed the wording. So it explicitly stated a user would use the data vs us recommending
    - mcmancini 12y ago
      Probably not sufficient. The patient is still using it to guide medical decisions. It would be worthwhile to speak to someone familiar with Canadian medical regulations.
      - icambron 12y ago
        I suspect you're right, but doesn't a weight scale help you make medical decisions too? Is that a medical device?
        mcmancini 12y ago
        For US market, a scale is a Class 1 medical device.
- yatoomy 12y ago
  What if we dont recommend treatment...more so utilizing the analytics they dont track. We wouldn't recommend, every case is different. That is between the user and their medical professional
  - mcmancini 12y ago
    I would guess that collecting data in this case could still fall under regulatory preview, and that you would also need to qualify your sensors (Pebble) too. It really would be best to speak to someone familiar with Canadian medical device data. Much cheaper to do things right from the start (e.g., develop under IEC 62304) than to fix things later after getting a nasty gram from the Canadian FDA equivalent. Maybe through very careful marketing you can work around potential problems, or maybe not. I think that this project is in an area that requires an expert opinion, however.

moberemk 12y ago

I'll have to look into that; offhand would you happen to know if there are any similar laws in Canada currently?

mcmancini 12y ago
IIRC, Canada largely follows CE. One other problem might be that you're using the Pebble sensors, and so that could fall under regulatory purview too.