Informational US FDA Final and update guidances – Software

Marcelo

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#1
Final and update guidances – Software

… the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. This guidance details the changes to existing guidance documents that relate to the regulation of the software functions. As such, the FDA updated the following final guidances to ensure consistent policy in the regulation of digital health products:


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duinyk

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#2
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?
 

duinyk

Involved In Discussions
#3
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?[/QUOTE

Also, if I classify the device as general wellness low risk device I understand FDA registration is not needed nor device listing right?
 
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