CORRECTED: CDRH New Update

The following new items were added to the CDRH web pages on November 6, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• October 2017 PMA Approval List
• 4th Quarter FY 2017 MDUFA Performance Report
• Webinar - PreCertification (Pre-Cert) Pilot Update - November 17, 2017
• Software Precertification Pilot Status Update
• Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of Total 25-hydroxyvitamin D Mass Spectrometry Test System
• Federal Register: Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
• Federal Register: General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
• Federal Register: Exemptions from Premarket Notification: Class II Devices
• Federal Register: Immunology and Microbiology Devices:Classification of Genetic Health Risk Assessment System