On a link on this page is a new pathway to get thru FDA
https://www.fda.gov/about-fda/cdrh-transparency/evaluation-automatic-class-iii-designation-de-novo-summaries
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices.
This must help us.
I wish RHY could feed us more innformation. Even when they do tell us things in passing like moving from lyell mcewin hospital SA to Concord Repat you have to wonder what it means.
Ann: Rhythm Extends ColoSTAT Clinical Trial to Western Australia, page-31
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