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Patient and Consumer Stakeholder Meeting Minutes, January 11, 2016
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Applying Human Factors and Usability Engineering to Medical Devices
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Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices
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List of Highest Priority Devices for Human Factors Review
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PMA Final Decisions for December 2015
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Full Program added to CDRH Industry Basics Workshop
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Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation
What is an Automated Endoscope Reprocessor? FDA’s Evaluation Validating AER Reprocessing Effectiveness AER Validation Testing Status Additional Resources What is an Automated Endoscope Reprocessor? Automated Endoscope Reprocessors (AERs) are important devices widely used in the health care setting to reprocess endoscopes, such as duodenoscopes, and endoscope accessories, to decontaminate them between uses. AERs are designed…
MDUFA III Independent Assessment of FDA Device Review Process Management
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Class I Medical Device Recall: Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings
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