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Summary Information for: Vysis CLL FISH Probe Kit
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Technical Considerations for Additive Manufactured Devices
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Waiver and Acknowledgment Letter posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting
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FDA-Industry MDUFA IV Reauthorization Meeting, April 6-7, 2016
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Mammography Facility Adverse Event and Action Report – May 04, 2016: Lake Havasu Imaging Center
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Added Webcast Archive and Presentations to Public Workshop – Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography
The Food and Drug Administration (FDA) announced a public workshop entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The topics discussed were 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) in the clinical…
Class I Medical Device Recall: B. Braun Medical Inc. Recalls Dialog+ Hemodialysis Systems Due Defective Conductivity Sensors
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Mammography Facility Adverse Event and Action Report
BackgroundAs part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022 added)
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