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by Ravinder Singh in Veeda Clinical Research on October 11
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Description FDA Releases Updated RTA Checklist

The guidance replaces the 30 October 2017 draft guidance of the same name and describes the administrative steps #FDA will take to either Refuse to Accept (RTA) or file a request for an evaluation of automatic class III designation (De Novo request).

https://lnkd.in/fx2ABH6

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