Talking about the guidance document on General wellness low risk device. If I had to import such a device are there any guidance that will relate to these?
Also, if I classify the device as general wellness low risk device I understand FDA registration is not needed nor device listing right? Can someone please give a brief insight as to how this works? Thanks
Also, if I classify the device as general wellness low risk device I understand FDA registration is not needed nor device listing right? Can someone please give a brief insight as to how this works? Thanks