CDRH New - December 20, 2019

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 19, 2019. To view listings for other dates, see CDRH New - News and Updates.

Consumer Information: LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047 Mammography Facility Adverse Event and Action Report - December 19, 2019: Radiology Disc of Encino Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy Transcripts posted for November 13-14, 2019 Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Federal Register: Neurological Devices: Reclassification of Cranial Electrotherapy Stimulator Devices Intended to Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended to Treat Depression