- So how did Tali train get this listing (not “approval” or “clearance” for assessment and not for treatment?
As far as I was aware they are exempt to streamline the review process and free up resources for more high risk medical devices. (drugs etc)
"The FDA’s finalized 510(k) exemptions follow the agency’s publication in March 2017 of a list identifying 1,003 Class II devices whose risks the agency argued were well enough understood that premarket notification reviews were not necessary. The agency identified the Class II devices for exemption in order to meet streamlining mandates of the 21st Century Cures Act of 2016."
https://www.emergobyul.com/blog/2017/07/us-fda-finalizes-class-ii-medical-device-exemptions-510k-premarket-notification
- So how did Tali train get this listing (not “approval” or...
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