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Summary Information for: MAMMOMAT Inspiration with Tomosynthesis
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Adaptive Designs for Medical Device Clinical Studies
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Public Meeting: Medical Device User Fee Reauthorization, July 13, 2015 (proposed)
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Presentations posted for May 14-15, 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
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Transcript Added to Public Workshop
The purpose of the workshop was to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aimed to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized…
Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling
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Emergency Use Authorizations (Added the EV-D68 2014 rRT-PCR Assay (CDC)
On November 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 for the presumptive detection of RNA from Ebolaviruses [such as Zaire ebolavirus (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus,…
Summary Information for: Nevro Senza Spinal Cord Stimulation (SCS) System
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Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety Communication
Date Issued: May 13, 2015 Audience: Health care facilities using the Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems Devices: Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems Purpose: The FDA is alerting users of the Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems to security vulnerabilities with these pumps. Summary of Problem and…