CDRH New Update

CDRHNew

Date: August 8, 2016

The following new items were added to the CDRH web pages on August 5, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and FDA Webinar on August 25, 2016
• Deciding When to Submit a 510(k) for a Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff
• Emergency Use Authorizations - xMAP® MultiFLEX™ Zika RNA Assay (Luminex Corporation)
• July 2016 PMA Approvals
• Meeting Notice: September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting Announcement
• Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of Meeting
• Second and Final Cohort of Results of the 2014-2015 Strategic Priority: Strike the Right Balance Between Premarket and Postmarket Data Collection (August 2016)
• Webinar Presentation and Transcript added to Next Generation Sequencing (NGS) Draft Guidances: Implications for Patients and Providers - July 27, 2016
• Webinar Presentation and Transcript added to Next Generation Sequencing (NGS) Draft Guidances: Technical and Regulatory Aspects - July 27, 2016