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Thanks for responding Anne.  According to the team, the app will have extra features/steps that are not all available in the device itself.   What if it was simply just for instructions? What would be the scenario with FDA? What if it interacts with the device to guide the user with certain steps ...

Fellow Rappers, I just wanted to know whether any of you have had experience in working with a medical device (cosmetic medical device), that has app guided features. Essentially, we would like the user to use the app as an accessory to follow steps to use the device in order to achieve the benefits ...

Hello fellow Rappers!!! FDA requires any registered product should have a responsible party for all the liabilities. However, at this moment, neither the owner of the 510(k) and US distributor (not the physical manufacturer), nor has the physical manufacturer regarded itself to be such party. In such ...

Great information Jennifer, thank you!  Cheers, Laura ------------------------------ Laura HoShue Regulatory Compliance Specialist Las Vegas, Nevada USA ------------------------------

As usual all great feedback from all of you.  I appreciate the feedback and the help always as this is all new territory for me.  Navigating through this and ensuring complete compliance is no easy feat and I lose too much sleep over it. Thank you ladies and gentleman!  Cheers, Laura ...