Training Course
Syllabus:
FDA's Regulation of Implantable and Wearable Sensors: 2-Day In-Person Seminar
Course Description: Sensors have begun to revolutionize human health due to their ability to provide real time health monitoring under a diverse set of conditions. For example, sensors can provide real time information such as heart rate, blood pressure, biomolecular concentrations, glucose levels, motion and exercise data, neural activity, and so much more. While wearable sensors have seen an explosion in use, the reliability of such data collected has been questioned. Moreover, very little has advanced in terms of implantable sensors, yet implantable sensor can provide much more in depth and variety of health data compared to wearable sensors. Implantable sensors also have the capability to reverse adverse health affects, whereas wearable sensors do not. This tutorial will provide an historical context for the use of wearable as well as implantable sensors in medicine, where the field has been and where it is going. It will also provide a few examples of FDA approved sensors in medicine and what is needed for the field to progress. Currently, there is an ongoing debate in industry on how such sensors should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as medical devices, drugs or simply biologics. Learning Objectives: Upon completing this course participants should have an understanding of: Fundamentals of sensors What is all the excitement about How to build sensors Wearable versus implantable sensors Incorporating cells and/or biological materials into sensors Avoiding immune system clearance of sensors Biological reactions to sensors FDA regulatory approvals for sensors Currently approved sensors in medicine FDA guidance documents for sensors Global approval of sensors How the FDA regulates sensors The medical device, drug and biological approval process Sensors for both diagnostic and therapeutic purposes How to design appropriate clinical trials Applicable good manufacturing and good laboratory practices Product labeling, marketing and advertising FDA and other federal agency enforcement action Future thoughts on approaches for the regulatory approval sensors Remaining hurdles Outlook for new technologies Course Outline: Day 1 (8:30 AM – 4:30 PM) Fundamentals of wearable and implantable sensors Definitions What is all the excitement about How to design and fabricate sensors Example of sensors Incorporating cells and biological into sensors Understanding biological responses to sensors Avoiding immune system clearance of sensors Research examples pre-clinical approval Research examples post-clinical approval FDA regulatory approvals for the use of sensors in medicine Currently approved sensors in medicine FDA guidance documents for sensors Global approval of sensors Day 2 (8:30 AM – 4:30 PM) FDA regulatory approvals for the use of sensors in medicine (continued) How the FDA regulates sensors The drug and biological approval process Medical device approval process How to design appropriate clinical trials Applicable good manufacturing and good laboratory practices Product labeling, marketing and advertising FDA and other federal agency enforcement action Future thoughts on the approaches for the regulatory approval of sensors Remaining hurdles Outlook for new technologies Strategies for commercializing sensors Questions |