CDRH New Update

Date: August 15, 2016

The following new items were added to the CDRH web pages on August 12, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Agenda posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
• Class I Medical Device Recall: BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS® easyMAG® Magnetic Silica for Nucleic Acid Extraction
• Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff
• Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff
• Webinar Presentation and Transcript added to Final Guidance on Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - August 8, 2016