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Meeting materials posted for March 15, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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Meeting materials posted for March 16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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MQSA Insights
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Letter to MD Biosciences regarding the Zika Virus RNA by RT-PCR Assay
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Presentations posted for February 25-26, 2016 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
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Public Workshop – Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs)…
Transcript posted for February 18, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers – Letter to Health Care Providers
March 8, 2016 Dear Breast Surgeons, Cardiac Electrophysiologists, Cardiologists, and Plastic Surgeons: The FDA is aware of reports of magnetic interference between breast tissue expanders with magnetic injection ports and either implantable cardioverter-defibrillators (ICDs) or pacemakers in patients, interfering with the functioning of these cardiac devices. The FDA analyzed peer-reviewed literature, device labeling, adverse event…
Alternative Standards #24: Approval of an Alternative Standard for Using the Quality Assurance Program Recommended by the ACR Digital Mammography Quality Control Manual for Full-Field Digital Mammography Systems, for Systems without Advanced Imaging Cap.
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