Grapefruit USA Inc (GPFT)

[KingKong_Guru]

Are we under De-novo review 510k process. DVIS is a novel device ...nothing exist in the market..which can be compared with DVIS...but there is very low risk in term s of safety ..low radiation...but ya De-novo take time for review ...and we know that ....
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The process for Evaluation of Automatic Class III Designation (also known as the de novo classification process) is meant to serve as a regulatory pathway for novel devices that cannot be cleared through the 510(k) process because they lack a clear predicate, but whose risks do not warrant a premarket approval (PMA) level of review. As currently implemented, the de novo classification process tends to be associated with lengthy review timeframes and nontransparent data requirements, making it an impractical path to market for many device developers. The 510(k) Working Group recommends that CDRH make major reforms in our implementation of the de novo process, including steps to streamline the process and clarify the Center’s evidentiary expectations for de novo requests.
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http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220782.pdf


IS_guru