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

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exports and exporting, fda requirements, medical devices
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  Post Number #1  
Old 1st July 2014, 04:06 AM
Jojo63

 
 
Total Posts: 30
Please Help! Exporting Add-On for Medical Devices to the US - FDA Requirements

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

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  Post Number #2  
Old 2nd July 2014, 06:36 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: Exporting Add-On for Medical Devices to the US - FDA Requirements

A Quick Bump!

Can someone help??

Thank you very much!!
  Post Number #3  
Old 3rd July 2014, 01:25 AM
Ronen E

 
 
Total Posts: 3,736
Re: Exporting Add-On for Medical Devices to the US - FDA Requirements

Hi Jojo,

A good starting point for you:

http://www.fda.gov/MedicalDevices/Pr...ns/default.htm

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #4  
Old 9th July 2014, 10:51 AM
Jojo63

 
 
Total Posts: 30
Re: Exporting Add-On for Medical Devices to the US - FDA Requirements

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