This course offers a comprehensive overview of the current European and U.S. Regulatory and Quality Affairs for in vitro diagnostic (IVD) products. You will gain a perspective on the critical elements of the regulatory requirements for obtaining IVD marketing approval. This course will take an extensive look into specific in vitro diagnostics topics and learn about the new and emerging regulatory requirements surrounding them. Learn about the impending transition for IVDs from the current European Directives (IVDD) to new substantially different European Regulations (IVDR), which will bring a majority of currently self-declared IVDs to require Notified Body involvement. Skills needed: "Quality Systems for Medical Devices: FDA QSR and ISO 13485" or working knowledge/experience in Quality Systems is needed.

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

• Discuss the current EU and US in vitro diagnostic device submission requirements
• Explain the EU list based and risk-based method for classification of devices in the US and new EU IVDR
• Understand how to create strategies to gain access to the current EU market
• Define actions that can be taken at this time to prepare and facilitate transitions in conformity with the forthcoming European Regulations (IVDR)
• Understand how to create strategies to gain access to the US markets
• Discuss the critical elements and core principles for IVD device development
• FDA’s jurisdiction in the design, testing, marketing and post-marketing of medical devices; risk assessment
• Explain the regulatory requirements for in vitro diagnostics manufactured in European healthcare institutions
• Explain the regulatory requirements for US laboratory developed tests (LDTs) and device manufacturer requirements for clinical laboratories
• Describe the diagnostic tests and test systems requirements to be issued a CLIA certificate of waiver
• Discuss the effects of regulation of IVD diagnostics in US clinical laboratories and EU healthcare institutions and its effect on the IVD device manufacturing industry

Topics Include

• Intro to IVDs
• IVD Submissions
• IVD Product Development
• Special Categories of IVDs
• Current Topics in IVD Regulatory
• Current Events in IVD Regulation - US and EU

Additional Information

This course will provide students with an understanding of the core elements in the in vitro diagnostic device industry. Topics will include a review of the European and US FDA regulatory frameworks, device classification system, routes to market, pre-market submissions, and post-market surveillance and change requirements. The regulatory approach will address the current requirements, future impending changes and what actions can be taken now to facilitate transitions. Application of quality system requirements as pertinent to IVD devices will also be covered. The course will be interactive, with student participation required, and will consist of lectures and case studies/examples, with three exams and a brief paper with references on a relevant topic of the student’s choice (approved in advance by the instructor).