Tag

recalls
FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reports
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398226.htm
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http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htm
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418469.pdf
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The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
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