Brief: Outset Medical Inc Says On July 6 Received Warning Letter, Dated July 5 From United States Food And Drug Administration

Outset Medical

07/07/2023 22:35

July 7 (Reuters) - Outset Medical Inc  OM.O :
    * OUTSET MEDICAL INC - ON JULY 6 RECEIVED A WARNING LETTER,
DATED
JULY 5 FROM UNITED STATES FOOD AND DRUG ADMINISTRATION
    * OUTSET MEDICAL INC - WARNING LETTER DOES NOT REQUEST
RESTRICTION
OF MANUFACTURE, PRODUCTION OR SHIPMENT OF TABLO SYSTEM IN UNITED
STATES
    * OUTSET MEDICAL INC - WARNING LETTER DOES NOT REQUEST
WITHDRAWAL
OF TABLO SYSTEM FROM U.S. MARKETPLACE
    * OUTSET MEDICAL-LETTER RAISES SOME MATERIALS REVIEWED BY
FDA
PROMOTE CRRT A MODALITY OUTSIDE OF CURRENT INDICATIONS FOR TABLO
HEMODIALYSIS SYSTEM
    * OUTSET MEDICAL INC - LETTER ASSERTS THAT TABLOCART WITH
PREFILTRATION REQUIRES PRIOR 510(K) CLEARANCE FOR MARKETING
AUTHORIZATION

Further company coverage:  OM.O 

 ((Reuters.Briefs@thomsonreuters.com;))