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

Seminar Summary:

Sensors have begun to revolutionize human health due to their ability to provide real time health monitoring under a diverse set of conditions.  (see full course description)

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