Exporting Add-On for Medical Devices to the US - FDA Requirements

[Jojo63]

Hi,

We will develop add-ons medical devices. These add-ons will be linked to a type of medical devices used for self-medication and the patient used to monitor treatment. These add-ons will have no impact on the dosage or length of treatment. They give any advice on what to do (eg. I reduce my treatment, I increase the intervals...). It is also expected that these add-ons send information to the Smartphone via Bluetooth.

If you want to export to the United States these additives, which rules should we follow? Should we have the FDA approval?

I think also at FCC for communications?

Thank you for your comments.


Jojo

 

[Stijloor]

A Quick Bump!

Can someone help??

Thank you very much!!

 

[Ronen E]

Hi Jojo,

A good starting point for you:

http://www.fda.gov/MedicalDevices/P...dHealth/MobileMedicalApplications/default.htm

Cheers,
Ronen.

 

[Jojo63]

Thank you Ronen. This is a good start to begin my investigations.