The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA) or are eligible for de novo requests. The program is detailed in the FDA’s guidance…
Emergency Use Authorization – Sentosa® SA ZIKV RT
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…
Meeting Notice: October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Technical Electronic Product Radiation Safety Standards 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 Technical Electronic Product Radiation Safety Standards Committee. The…
Presentation and Transcript posted for the Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies Webinar
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National Evaluation System for health Technology
The FDA is building the foundation for a National Evaluation System for health Technology (NEST) to more efficiently generate better evidence for medical device evaluation and regulatory decision-making. A national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to…
Reporting of Computational Modeling Studies in Medical Device Submissions
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Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
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FY2017 Regulatory Science Priorities
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24 Hour Summary posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting
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Transcript posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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