Brief: Arocell Informs About FDA Feedback Regarding 510(K) Application

IDL Diagnostics AB (publ)

10/08/2021 15:42

Aug 10 (Reuters) - AroCell AB (publ)  AROC.ST :
    * AROCELL INFORMS ABOUT FDA FEEDBACK REGARDING 510(K)
APPLICATION
    * AFTER DISCUSSION WITH FDA, CONCLUDED THAT PREDICATE DEVICE
CHOSEN FOR AROCELL'S 510(K) APPLICATION IS NOT POSSIBLE GIVEN
INTENDED USE
    * AROCELL HAS DECIDED TO WITHDRAW 510(K) APPLICATION IN ITS
CURRENT FORM
    * 510(K) ROUTE IS NOT APPLICABLE FOR THIS 510(K) APPLICATION
    * AROCELL, IN DISCUSSION WITH FDA, WILL NOW EVALUATE
POSSIBILITY
OF A SO-CALLED DE NOVO PROCESS USED IN CASES WHEN A PREDICATE
DEVICE IS MISSING.

Source text for Eikon:  ID:nMFN8ZXhPt 
Further company coverage:  AROC.ST 

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