CDRH New Update

CDRHNew

Date: March 15, 2017

The following new items were added to the CDRH web pages on March 14, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display
• Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use
• Federal Register: Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments
• Federal Register: Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device
• Class I Medical Device Recall: Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall