Coronavirus (COVID-19) Update
Fall classes are offered remotely—either live-online with an instructor, entirely self-paced, or in a blended online format. Please check our coronavirus update page for our latest announcements.
Post-Market Regulatory Obligations for Medical Devices
Once medical devices are on the market, manufacturers are required to follow specific requirements and regulations. This includes investigating complaints, submitting to the FDA's eMDR system for reporting device malfunctions, injuries or deaths; handling recalls, managing post-market surveillance studies requirements under section 522 of the Federal Food, Drug and Cosmetic Act, as well as post-approval studies required at the time of approval of a premarket approval (PMA); and handling advertising and promotional labeling. This course offers the opportunity to apply these post-market regulatory requirements via in-class activities using case studies.
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