Tag Archives: FDA

Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com

Health Hazard Evaluations: Focus on Complaints and the Patient

By Maria Fontanazza
Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com

When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device.  During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…

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