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Webinar Presentation and Transcript added to Next Generation Sequencing (NGS) Draft Guidances: Technical and Regulatory Aspects
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Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and FDA Webinar on August 25, 2016
Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes. Medical device technology is constantly evolving, and…
Deciding When to Submit a 510(k) for a Change to an Existing Device
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Deciding When to Submit a 510(k) for a Software Change to an Existing Device
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Emergency Use Authorizations
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
July 2016 PMA Approvals
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Meeting Notice: September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting Announcement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] National Mammography Quality Assurance Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the National Mammography Quality Assurance Advisory Committee. The general function…
Second and Final Cohort of Results of the 2014-2015 Strategic Priority: Strike the Right Balance Between Premarket and Postmarket Data Collection (August 2016)
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Class I Medical Device Recall: Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage
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