FDA Registration - MD, OTC or Dietary Supplement

D

depa1978

#1
Hi everyone,

I am exploring the possibility to register an alginate based product intended for GERD (gastroesophageal Reflux Disease) as a medical device in US, but it seems nobody have done the same till now (so there is no predicate :frust:--> PMA).

Anybody knows if the reason is that FDA does not accept this products as Medical Devices? Should I only register the product as OTC? Or dietary supplement if I overlook alginates and put the attention on other basic ingredients?

In Europe is quite usual to register such products as Medical Devices (Sanofi, GSK, Aboca and many others do this).

Thanks in advance!
 
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