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.

Necessary Knowledge

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and an essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe the principal post-market regulatory obligations for medical devices distributed in the United States.
• Apply regulations and FDA guidance in order to maintain post-market regulatory compliance.
• Document complaint investigations, file MDRs, complete health hazard evaluations, analyze advertisement and promotional content, and manage post-market study reporting needs.

Topics Include

• Complaints and Mandatory Reporting Requirements
• Recalls, Corrections, and Removals
• Post-approval studies & 522 Postmarket Surveillance Studies
• PMA Supplements, Annual Reports, 510(k) Modifications, etc.

Additional Information