The primary goal of this course was to analyze the overall framework for the regulation of medical devices in the United States throughout the product lifecycle, including the origins and rationale for regulatory requirements, design, and quality testing and standards. Principle topics included US Medical Device Regulations, medical device classification, controls, routes of submission to the US Food and Drug Administration (FDA) 510(k) submission, Premarket Application (PMA), Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), and Pediatric), standards, testing, labeling, legal enforcement of the US Code of Federal Regulations (CFRs), FDA actions, design control, post-market surveillance, and working with the FDA.
- Differentiate the role of the clinical research monitor from other clinical research professionals.
- Compare and contrast medical device development within the U.S. to medical device development outside of the U.S.
- Apply project management concepts to the medical device timeline, including testing, standards, quality and risk management assessments, quality systems, surveillance and reporting required to support device approval and marketing throughout the product life cycle.
- Apply the FDA’s guidance documents, expectations, and industry best practices for device promotion, labeling, advertising, and other marketing issues to medical device submissions.
- Collaborate in a team environment to research and prepare a 510(k) Submission and presentation.
- Interpret applicability of special and current industry topics and issues for device development and regulatory strategy.