22414 Post-Market Regulatory Obligations for Medical Devices

Once a medical device has received regulatory approval or clearance, it is subject to continuing regulation in the form of record keeping and reporting to the FDA. Understanding and preparing for these obligations during the submission phase yields advantages in post-marketing. This course helps regulatory affairs professionals understand their post-market regulatory obligations and provides perspective on how efficient and robust systems can be put in place prior to market release. Topics of discussion include complaint handling, adverse event reporting, MDR/Vigilance Reporting, device tracking, post-market studies, annual reports, and the conduct of voluntary recalls. This course will focus primarily on the post-market regulatory obligations for medical device manufacturers distributing products within the United States. Requirements for other regulatory agencies will also be discussed, including reporting requirements to clinicaltrials.gov, reporting of financial arrangements to state and federal agencies, and the guidelines of industry trade organizations and the Office of the Inspector General.

"Regulation of Medical Devices and Diagnostics" or equivalent experience in the medical device industry.

Certificate Program in Regulatory Affairs