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.

Prerequisites :


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics